Myopia: Clinical Guidelines

List of Abbreviations

SAD — scleral acoustic density

BAR — binocular accommodative response

APR — annual progression rate

dB — decibel, unit of measurement in acoustics

D — diopter

RAR — relative accommodation reserve

IOL – intraocular lens

MAR — monocular accommodative response

ICD — International Classification of Diseases

AAA — amplitude of absolute accommodation

OAA — objective accommodation response

OKL — orthokeratology lenses

OOA — amplitude of relative accommodation

PVHRD — peripheral vitreochorioretinal dystrophy

AL — anteroposterior axis of the eye

PINA — habitual excessive accommodation strain

PD – prism diopter

PTA — habitual accommodation tone

TPA — accommodation resting tone

mCNV — myopic choroidal neovascularization

ISO – International Organization for Standardization

Standartization)

FATT – unit of measurement for contact lens oxygen permeability

Terms and Definitions

Congenital myopia is a specific form of myopia that develops during the intrauterine development of the fetus. Myopia of moderate and high degrees detected at the age under 3 years is generally considered congenital.

Orthokeratology lenses (OKL) are rigid gas-permeable contact lenses of the so-called "reverse geometry" design, which reduce or eliminate refractive errors—myopia and astigmatism—through the programmed modification of the shape and optical power of the cornea. They are used in an overnight wear modality.

Habitual excessive accommodation strain (PINA) is a long-standing excessive accommodation tone that causes myopization of manifest refraction without reducing the best-corrected visual acuity.

Pseudomyopia is a condition in which the manifest refraction is myopic, while under cycloplegia it is emmetropic or hyperopic.

Early-acquired myopia is a form of myopia that develops in the preschool period and often tends to progress rapidly.

Late-acquired myopia is myopia that develops at the age over 18 years.

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Myopia (from Greek *myo* – to squint and *ops* – eye) or nearsightedness is a disproportionate type of eye refraction in which parallel rays of light are focused in front of the retina, and a circle of light scatter is formed on the retina. Myopia is the most frequent cause of deterioration in distance visual acuity. The diagnosis is established if the myopic refraction under conditions of cycloplegia is 0.5 diopters or more. In unfavorable cases, myopia causes the development of retinal complications, strabismus, decreased corrected visual acuity, and in severe cases leads to disability at working age.

School-aged acquired myopia, is the most common form. Decisive importance in the development of "school" myopia is attributed to near-vision work, especially under unfavorable hygienic conditions, burdened heredity, and accommodation weakness. The signal indicating excessive accommodation strain, which is continuously transmitted to the eye growth control center, prompts it to alter the optical system so as to adapt it to near work without accommodation strain. This is achieved mainly through a moderate elongation of the anteroposterior axis (AL) of the eye.

1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)

The concept of the etiology and pathogenesis of myopia in children is reflected in the three-factor theory of myopia origin proposed by Professor E.S. Avetisov (1999). He developed a model of refractogenesis characteristic of myopia. This theory suggests that the main factors in the origin and progression of myopia are weakened accommodation, hereditary (genetic) predisposition, and weakening of the scleral supporting properties. General somatic diseases, metabolic disorders in the connective tissue system, and other factors, which are often assigned a leading role in the origin of myopia, favor the transition of the cause (near work under conditions of weak accommodation capacity) into the consequence—myopic refraction [1].

The rapid spread of myopia in recent decades in various parts of the world cannot be explained solely from the standpoint of heredity; genetic changes occur too slowly to cause a "myopia boom" [2]. Fundamental experimental animal studies have demonstrated the important role of the visual environment and, in particular, the nature of the optical focusing of the image relative to the retina in regulating eye growth and refraction formation [3,4]. Optical defocus of various signs induced biochemical signaling cascades causing changes in the retina, retinal pigment epithelium, choroid, and ultimately in the scleral matrix [4,5,6,7]. Hyperopic defocus in the fovea (when the focal plane is located behind the retina) accelerated eye growth, whereas myopic defocus (when the focal plane is located in front of the retina), conversely, acted as a signal to slow down its growth. Animal studies have provided convincing evidence that not only central but also peripheral defocus can influence refractive development. The retinal periphery, independently of the fovea, could respond to optical signals by altering the pattern of eye growth depending on the sign of defocus, including within a limited area [8,9,10].

Summarizing the data from experimental studies, J. Wallman and J. Winawer emphasize that visually guided eye growth is controlled by a cascade of locally produced chemical substances—neurotransmitters and neuromodulators—secreted by the retina and causing changes in the scleral matrix depending on the sign of defocus, accelerating or slowing down eye growth [5]. Given that the role of accommodation is to ensure clear vision of objects at various distances, near focusing depends entirely on its function. An accommodation response that does not match the accommodative demand is the source of hyperopic defocus, which apparently triggers the entire cascade of signals for eye growth. Thus, the role of accommodation, specifically its weakness, in the development of acquired myopia remains unchanged [1,11,12,13,14,15,16].

1.3 Epidemiology of the Disease or Condition

The development of myopia generally coincides with the period of school education, which ensures its high prevalence among both the pediatric and adult populations. It is projected that by 2050 the number of myopic individuals in the world will reach 5 billion, and about half of the Earth's inhabitants will become myopic, while in Europe this figure will reach 56.2% [17], entailing significant clinical and economic consequences [18]. According to the results of the all-Russian medical examination, the incidence of myopia among children and adolescents increased 1.5-fold between 1990 and 2000. By 2000, the frequency of myopia among school graduates reached 25–30%, among gymnasium and lyceum graduates—50%, with high myopia accounting for 10–12% [19]. By 2017–2018, the prevalence of myopia among 1st-grade students was 2.4%, among 5th-grade students—19.7%, and among school graduates—38.6%, while among gymnasium graduates this indicator reached 50.7% [20]. The highest prevalence rates of myopia are registered in the populations of East and Southeast Asian countries—up to 96% [21,22,23,24]. There is evidence of an increase in its prevalence in European countries [18] and the USA [25,26]. It is assumed that the increase in myopia prevalence is associated with a higher level of education [18,27]. Among adults born in the first three decades of the 20th century, the prevalence of myopia was less than 10%; among those born in the second half of the 20th century, the prevalence of myopia increased to 21–30% [28]. Despite the undoubted successes achieved in recent years in the prevention and treatment of this disease, it frequently leads to irreversible changes in the fundus and a significant decrease in vision at a young, working age.

The conditions for the onset of complicated myopia are laid down during the period of active myopia progression, which coincides with schooling. The detection, prevention of development and progression of myopia and its complications must be carried out precisely during this period [19].

1.4 Features of Coding the Disease or Condition

H52.1 - Myopia.

1.5 Classification of the disease or condition

In clinical practice, the classification proposed by Professor E.S. Avetisov (1999) is most frequently used [1].

Clinical classification of myopia (according to E.S. Avetisov)

By degree:

- Low degree (up to 3.0 D);

- Moderate degree (3.25–6.0 D);

- High degree (6.25 D and more).

By age of onset (clinical forms of myopia):

- Congenital;

- Early-acquired (in preschool age);

- School-aged acquired;

- Late-acquired (in adulthood).

By interocular refraction difference:

- Isometropic;

- Anisometropic.

By presence or absence of astigmatism:

- Without astigmatism;

- With astigmatism.

By course:

- Stationary;

- Slowly progressive (less than 1.0 D per year);

- Rapidly progressive (1.0 D or more per year).

By presence or absence of complications:

- Uncomplicated;

- Complicated.

By stage of functional changes in a complicated course (best-corrected visual acuity):

I. Visual acuity 0.8–0.5;

II. Visual acuity 0.4–0.2;

III. Visual acuity 0.1–0.05;

IV. Visual acuity 0.04 and lower.

The International Myopia Institute (IMI) suggests distinguishing myopia into:

- Axial;

- Refractive [29].

Such a classification was proposed by E.Zh. Tron as early as 1934 [30,31] and remains important for determining the feasibility of surgical interventions in myopia. However, clear criteria for differentiating these two forms based on axial length have not been established.

For the clinical assessment of peripheral dystrophies occurring in the complicated course of myopia, the classification by William L. Jones, 2006 is used [32]. It is very detailed and distinguishes: I. Conditions predisposing to retinal detachment (rhegmatogenous degenerations); II. Conditions not predisposing to retinal detachment (non-rhegmatogenous); III. Retinal tears.

Peripheral retinal degenerations

I. Conditions predisposing to retinal detachment (rhegmatogenous degenerations):

1.1. Lattice degeneration;

1.2. Snail-track degeneration;

1.3. Vitreoretinal tufts:

1.3.1. Non-cystic retinal tufts;

1.3.2. Cystic retinal tufts;

1.3.3. Retinal tufts with zonular traction.

1.4. Meridional folds, isolated bays of the ora serrata, and peripheral retinal excavations;

1.5 "White-without-pressure" and "white-with-pressure" degeneration.

II. Conditions not predisposing to retinal detachment (non-rhegmatogenous):

2.1. Paving-stone (cobblestone) degeneration;

2.2. RPE hyperplasia;

2.3. RPE hypertrophy;

2.4. Peripheral cystoid degeneration;

2.5. Ora serrata pearls;

2.6. Retinal drusen;

2.7. Frost-like degeneration.

III. Retinal tears:

3.1 Flap or horseshoe tear;

3.2 Giant tear;

3.3 Tear with an operculum;

3.4 Avulsion (dialysis);

3.5 Holes (atrophic retinal breaks)

The most convenient for the clinical evaluation of pathological changes in the central fundus in myopia are the International Photographic Classification and Grading System (META-PM) [33] (Table 1) and the ATN classification system, which accounts for the atrophic (A), tractional (T), and neovascular (N) components (Table 2) [34].

Table 1. International Photographic Classification and Grading System for Myopic Maculopathy (META-PM)

Three additional features supplementing these categories were defined as "plus" lesions: lacquer cracks, mCNV, and Fuchs spot.

Table 2. ATN classification system for myopic maculopathy, accounting for the atrophic (A), tractional (T), and neovascular (N) components [34]

1.6 Clinical presentation of the disease or condition

Patient complaints are limited to decreased distance visual acuity.

Decreased distance visual acuity usually appears at the age of 9–10 years, sometimes earlier. Cases of decreased distance visual acuity in preschool age are referred to as early-onset myopia; it more frequently develops in children who learn to read and write early, use digital devices, and in children with pseudomyopia. Myopia is frequently detected in children of myopic parents [35,36,37,38,39,40]. Children with myopia frequently suffer from acute respiratory infections and have chronic diseases [41,42].

Objective refraction measurement reveals myopic refraction under non-cycloplegic and cycloplegic conditions. Upon visometry, uncorrected distance visual acuity is reduced. When negative lenses fully compensating for myopic refraction are placed before the eye, visual acuity increases to 1.0 or higher. Relative accommodation reserves (RAR) are lower than age-related normal values. Repeated refraction measurements in children reveal a higher degree of myopia in the majority of cases—the disease tends to progress, which is particularly pronounced at the age under 14–16 years. In adults, myopia is most often stable; however, against the background of significant visual load, severe somatic diseases, stress, etc., late-onset myopia may develop or previously stable myopia may progress.

In myopia, binocular functions are preserved in most cases. No alterations of the anterior segment of the eye are detected. Media are typically clear, but in high and especially congenital myopia, vitreous body destruction is observed [43,44].

Peripapillary fundus changes are widespread in children and adults with myopia, among which light arc reflexes, myopic cones (crescent, true cone, and circular cone or false staphyloma) are commonly distinguished. Degenerative myopia is characterized by the formation of a true staphyloma—a protrusion of the posterior segment of the eye representing posterior scleroectasia. The prevalence of true staphylomas increases from 1.4% in eyes with an axial length of 26.5–27.4 mm to 71.4% with an AL of 33.5–36.6 mm [45,46].

In children, central zone changes are generally not observed, with the exception of congenital myopia. In congenital myopia, changes in the paramacular region and myopic maculopathy develop already in childhood [43,44,47,48].

Pathological changes in the macular region (occurring predominantly in adults) during the development of degenerative myopia include a tessellated ("tiger-stripe") fundus, lacquer cracks (linear or stellate ruptures in Bruch's membrane, retinal pigment epithelium, and choriocapillaris), diffuse and patchy chorioretinal atrophy, mCNV, and macular atrophy, as well as various variants of tractional changes [49].

Characteristic dystrophic changes are observed in the peripheral fundus in children and adults [32,50,51,52,53,54,55]. See also the clinical guidelines "Peripheral Retinal Degenerations".

2. Diagnostics, medical indications and contraindications for diagnostic methods

Criteria for establishing the diagnosis of myopia: based on refraction examination under cycloplegia — spherical equivalent refraction values corresponding to myopic refraction of 0.5 D or greater [29].

2.1 Complaints and Anamnesis

Comments: complaints – patients with myopia present with complaints of decreased distance visual acuity. In cases of high and congenital myopia, patients complain of decreased distance and near visual acuity.

History of the present illness – time of detection of myopia. When the first glasses were prescribed. When the last glasses were prescribed and which ones. Refraction dynamics (according to previous examinations, previously dispensed glasses, from the patient's words). What treatment was received previously.

Personal history – family history of myopia. Characteristics of the mother's pregnancy and childbirth. Past illnesses. Presence of other diseases and allergies. Characteristics of visual load, physical education, sports, and other activities. Characteristics of the area of residence. Time spent outdoors.

2.2 Physical Examination

Comments: joint hypermobility is assessed by five criteria:

1) ability to passively bring the thumb to the flexor surface of the forearm;

2) passive hyperextension of the metacarpophalangeal joints by more than 60 degrees;

3) hyperextension of both elbow joints by more than 10 degrees;

4) hyperextension of both knee joints by more than 10 degrees;

5) ability to touch the floor with palms when bending forward with knees straight.

If three or more signs of joint hypermobility are detected, along with other signs of connective tissue pathology, the patient is diagnosed with an increased risk of impaired scleral supporting function and progressive myopia.

2.3 Laboratory Diagnostics

2.4 Instrumental Diagnostics

Comments: visometry in children under three years of age is performed approximately – determining whether the child has object vision. More precise measurement is possible using the preferential looking test or optokinetic nystagmus recording [69, 70].

Visometry in children aged three years and older is performed using charts: from 3 years of age, using the children's silhouette picture chart [69, 70].

In children over 5 years of age and in adults, visometry is performed using Landolt rings or "E" tests. These results are the most accurate.

The value of visual acuity is taken as the chart line in which all symbols are correctly identified.

Comments: subjective refraction assessment determines the weakest negative lens that achieves maximum visual acuity [1, 68]. In children, subjective refraction is performed as soon as age permits.

Comments: for diagnostic refraction testing, instillation of 1–2 drops of 1% tropicamide** eye drops into the conjunctival sac twice with an interval of 5 minutes induces less profound cycloplegia than 1% cyclopentolate [73, 74].

Comments: to achieve maximum cycloplegia, #atropine** 1% is instilled twice daily for 3 days; on the fourth day, #atropine** is instilled once 1–2 hours before the ophthalmological examination [70]. Instillations of #atropine** 1% are used when the use of 1% cyclopentolate and 1% tropicamide** is impossible due to allergies or other reasons, or when 1% cyclopentolate and 1% tropicamide** fail to induce sufficient cycloplegia for refraction testing. Atropine** eye drops of other concentrations are not registered in the state register of medicines.

Comments: peripheral refraction is studied in research settings to predict the course of progressive myopia.

Relative peripheral hyperopia, or hyperopic peripheral defocus, accelerates eye growth and the development of myopia. Relative peripheral myopia, or myopic peripheral defocus, inhibits eye growth and the progression of myopia [76, 77, 78, 79, 80, 81, 82].

To determine peripheral refraction, the refraction corresponding to the periphery of the nasal and temporal retinal zones is measured at a metered gaze deviation of 15º or 30º in the respective direction, and the axial (central) refraction is subtracted from it. The algebraic difference indicates the magnitude and sign of peripheral defocus [81].

For example, R_center = -5.0 D, R_periph = -4.0 D. (-4.0) – (-5.0) = 1.0. Relative peripheral hyperopia of 1.0 D.

of evidence – 5)

Comments: amplitude of absolute accommodation (AAA)– the difference in refraction of one eye when focused on the nearest (punctum proximum, p.p., PP) and furthest (punctum remotum, p.r., PR) points of clear vision, expressed in diopters. AAA is measured monocularly.

Amplitude of relative accommodation (ARA) – the difference in refraction under conditions of maximum accommodation tension and relaxation during binocular fixation of a stationary object located at a finite distance from the eye, expressed in diopters.

ARA is measured binocularly, with the text placed at a distance of 33 cm under conditions of full distance correction and presence of binocular vision.

The positive and negative parts of relative accommodation are determined: the maximum tolerated power of negative and positive lenses when reading text with both eyes corresponding to a visual acuity of 0.7 (text No. 4 of the D.A. Sivtsev chart). The sum of the absolute values of the positive and negative parts constitutes the ARA.

Special importance is attached to the positive part of relative accommodation – the power of the maximum negative lenses – the positive relative accommodation (PRA) reserve. It is designated as PRA. This is the reserve (unexpended) part of accommodation that can potentially be used. A decrease in PRA indicates a high risk of myopia onset and progression. An increase in PRA is a favorable criterion when assessing the effectiveness of treatment and the prognosis of myopia progression.

The negative (expended) part of relative accommodation, determined using positive lenses, also has diagnostic value.

When reading text at a distance of 33 cm under full correction of ametropia, the negative part of relative accommodation should be 3.0 D. Lower values indicate undercorrection (i.e., inadequate correction) of existing myopia or accommodation spasm, while higher values indicate overcorrection of myopia. In both cases, clarification of objective cycloplegic refraction is required.

Normal age-related values of PRA and NRA are presented in Table 3.

Table 3. Normal age-related values of accommodation parameters

PRA values greater than 5.0 D are always overestimated. Obtaining overestimated PRA values indicates a dissociation between accommodation and convergence, the exclusion of one eye from the reading process, and the recording of absolute rather than relative accommodation [83,88].

Comments: methods are based on the objective recording of changes in dynamic refraction in response to a change in the accommodative stimulus—the objective accommodative response (OAR). In patients with progressive myopia, the OAR is usually reduced. An increase in the OAR is a favorable criterion when assessing the effectiveness of treatment and the prognosis of myopia progression [88,89].

Methods of objective accommodometry, computer accommodography, and dynamic retinoscopy (skiaskopy) are used [88,89,90,91,92].

Objective accommodometry makes it possible to study the OAR, which is measured under conditions of emmetropization at various distances. During binocular fixation, the binocular accommodative response (BAR) is measured, and during monocular fixation, the monocular accommodative response (MAR) is measured [89].

Computer accommodography allows for the graphical recording of changes in eye refraction when presenting a visual stimulus at different distances in the form of a bar chart. In addition to the magnitude of the accommodative response to the presented standard stimulus, the device analyzes accommodative microfluctuations using the Fourier transform method. Computer accommodography allows not only for a quantitative but also a qualitative assessment of the ciliary muscle function and monitoring of its state during treatment [91,92].

Comments: AL determination is recommended as the primary diagnostic method and is performed at least once a year. SAD determination is recommended as an additional study method.

AL determination has diagnostic value in the differential diagnosis of myopia and accommodation spasm.

Comments: dystrophic changes in the peripheral and central retina serve as the direct cause of the reduction and loss of visual functions in complicated myopia, often leading to the development of retinal detachment [52,53,54,55,98,109]. Dystrophic changes in the central fundus occur: in childhood only in congenital myopia (lacquer cracks, coin-shaped hemorrhages, and neovascular membranes); in adolescence (after 14 years of age) in congenital and early-acquired myopia; in so-called school myopia, myopic maculopathy occurs only in adults, usually after 30 years of age [52,54,55].

Peripheral vitreochorioretinal dystrophies (PVCRD) in all forms of myopia develop already in childhood, and their frequency significantly increases with age, degree and rate of myopia progression, size of the eyeball, and duration of the disease. The "peak accumulation" of PVCRD in children and adolescents is the age of 11-15 years, when their frequency increases 3-4 times. The most frequent localization of lattice degeneration and retinal tears is the upper parts of the temporal half of the fundus, as well as the 11-13 and 5-7 o'clock zones. It is these parts of the fundus that require particularly careful examination during ophthalmoscopy [53,54,109].

Comments: the classification by E.O. Saksonova et al. [52] is more convenient for clinical and scientific purposes, is used to describe the fundus in myopia [53,55,67,115], and is more widespread in our country than the more detailed classification by W.L. Jones, 2006 [32]. The classification of PVCRD by E.O. Saksonova et al. is presented in Table 4.

Table 4. Classification of PVCRD by E.O. Saksonova et al.

Comments: to measure intraocular pressure in children and adults, the following are performed: Maklakov applanation tonometry (under local anesthesia); non-contact tonometry (used for screening); indentation tonometry, Goldmann tonometry (under local anesthesia); digital palpation or transpalpebral tonometry (if the above methods cannot be performed [120,121]).

Maklakov intraocular pressure values increase by approximately 0.5 mmHg per year from birth to age 12, rising from 12±2 mmHg at birth to 18±3 mmHg by age 12. Progression of myopia can occur against IOP values corresponding to the upper limit of normal (18–22 mmHg – 31% of cases), mid-normal values (14–17 mmHg – 49% of cases), and the lower limit of normal (8–13 mmHg – 20%).

At high IOP values (24–28 mmHg by Maklakov) in children and adults with progressive myopia, and in adults over 40 years of age with progressive myopia at any IOP values, corneal pachymetry is required (A03.26.011). In 98% of cases, an increase in central corneal thickness to 550 μm or more is detected. In such cases, correction of IOP readings is not required. In 0.5–1% of cases in adolescents with myopia and central corneal thickness of 550 μm or less, increased IOP may indicate juvenile glaucoma [116,117].

Comments: habitual accommodative tone (HAT), or tonic accommodation, is the difference between manifest and cycloplegic refraction.

Tonic accommodation / resting state of accommodation (RSA) is the optical focal state of the eye in the absence of a visual stimulus.

Positive HAT is characteristic of hyperopic eyes and promotes full or partial compensation of hyperopia through accommodative effort to achieve clear vision. Negative HAT (manifest refraction is weaker than cycloplegic refraction) is rarely seen in myopic eyes (5% of cases) [122]. To measure HAT, autorefractometry is performed or subjective refraction values under natural and cycloplegic conditions are compared. High HAT values indicate ciliary spasm / persistent accommodation accommodation excess (PIAN) and are associated with a potentially high rate of myopia progression. Measuring RSA is recommended as an adjunct method. High RSA values are also associated with a higher rate of myopia progression. A decrease in HAT and RSA after treatment is a favorable prognostic sign for the future course of myopia [56].

2.5 Other Procedures

3. Treatment, including drug and non-drug therapies, diet therapy, and pain management

3.1. Optical correction

Comments: when prescribing optical correction, the following should be considered: the degree of myopia, the state of accommodation, convergence, binocular vision, and age.

Comments: peripheral defocus plays a significant role in refractogenesis [133,134,137]. Peripheral defocus refers to the relative decrease or increase in refractive power moving from the fovea to the peripheral retina. In the former case, this is called relative peripheral hyperopia, or hyperopic defocus; in the latter – peripheral myopic defocus. Hyperopic defocus at the retinal periphery stimulates axial eye elongation and development of axial myopia, whereas myopic defocus, on the contrary, inhibits refractogenesis [78,82,138,139,140].

Special corrective spectacle lenses of various designs can induce low myopic defocus onto the corresponding areas of the mid-peripheral retina [11,103,128,129,131,132,141].

Spectacle lenses designed to create peripheral myopic defocus include progressive/multifocal lenses designed for central vision correction with perifocal increase in peripheral refractive power [130,131,132,133,], single-vision spectacle lenses with integrated rings of highly aspheric lenslets (H.A.L.T.) generating a slowdown signal volume in front of the retina [125,126,128,129,134,142], and single-vision spectacle lenses incorporating multiple defocus segments (D.I.M.S.) [103,127].

Spectacles with progressive/multifocal corrective spectacle lenses designed for central vision correction and peripheral perifocal power increase allow differential correction of central and peripheral ocular refraction along the horizontal meridian and induce myopic (or reduce hyperopic) peripheral defocus in myopic eyes [131,132,133]; when used, they increase accommodative facility and induce positive spherical aberration in the eye. By creating relative peripheral myopic defocus at 15° and even 30° from the fovea, spectacles help slow myopia progression. After 4–5 years of continuous wear of such spectacles, refraction remained stable compared to baseline in 37.5% of cases, and regression was observed in 3.6%. In the remaining cases, refraction increased: mildly by 0.63–1.0 D in 28.6% of cases, by 1.12–2.0 D in 21.4% of cases, and by more than 2.0 D in 8.9% of cases; the annual progression rate (APR) was 0.26 D/year, and axial length (AL) increased on average by 0.46±0.05 mm compared to baseline values. In the control group of children wearing spectacles with single-vision corrective lenses, the mean APR was 0.44 D/year, and AL increased by 0.71±0.09 mm [130]. Corrective spectacles with progressive/multifocal lenses with zero or plus central power can be used for pseudomyopia and other predictors of myopia development in children [39,40,132,133].

Wearing spectacles with single-vision lenses incorporating rings of highly aspherical lenslets reduced myopia progression by up to 67% over two years of follow-up in Chinese children. The increase in refraction was 0.48±0.1 D, and the increase in axial length was 0.28±0.04 mm, provided the spectacles were worn for more than 12 hours a day. In the control group, the increase in refraction was 1.44±0.1 D, and the increase in axial length was 0.69±0.04 mm [126]. In Russian children, myopia progression decreased by 79% over two years of follow-up. The increase in refraction was 0.2±0.06 D, and the increase in axial length was 0.15±0.03 mm. In the control group wearing single-vision lenses without rings of highly aspherical lenslets, the increase in refraction was 0.95±0.08 D, and the increase in axial length was 0.48±0.04 mm [135].

Wearing spectacles with single-vision lenses incorporating multiple defocus segments slowed myopia progression over two years. The increase in refraction was 0.34±0.52 D, and the increase in axial length was 0.20±0.21 mm. In the group wearing single-vision lenses without defocus segments, the increase in refraction was 0.87±0.59 D, and the increase in axial length was 0.49±0.24 mm [127].

Comments: in cases of sharply reduced accommodation and poor spectacle tolerance, undercorrection by no more than 0.5 diopters weaker than the cycloplegic refraction is possible

Comments: one eye is corrected to achieve (in spectacles!) a residual myopia of -0.5 diopters, the other eye is corrected to achieve a residual or induced myopia of -1.5 diopters. Binocular vision and high corrected binocular visual acuity are preserved. Two pairs of spectacles (with alternating defocus) are prescribed to be worn every other day. Spectacles are recommended for children aged 7–11 years with low myopia and eso- or orthophoria [100,146,147].

Comments: single-vision corrective spectacles and contact lenses that do not affect peripheral refraction maintain or even increase hyperopic defocus across virtually the entire field of view in any gaze direction [11,81,141,148,149,150], and also induce negative spherical aberration in myopic eyes [149,151,152].

Comments: permanent correction with an addition of 0.75–3.0 diopters is prescribed: [66,68,86,87].

Comments: the spherical component correction is prescribed 2.0 diopters weaker than the objectively determined refraction, near-full astigmatism correction and maximally full correction of the refractive difference between the two eyes (up to 6.0 diopters) are prescribed, and contact lens correction should be used whenever possible.

Comments: the advantages of contact lenses over spectacles include a clearer retinal image, reduction of aberrations, absence of prismatic effect, and no restriction of the visual field by the spectacle frame.

Comments: to prevent the progression of myopia in children with congenital myopia, moderate and high myopia, and anisometropia, it is advisable to additionally prescribe spectacles that create peripheral myopic defocus alongside contact lenses. This combination of two correction modalities is called bioptics [11].

Comments: orthokeratology – a method for the temporary reduction or elimination of refractive anomalies: myopia and astigmatism, achieved through programmed modification of corneal shape and optical power using rigid gas-permeable contact lenses for overnight orthokeratology wear. Modern orthokeratology utilizes complex design lenses known as "reverse geometry" lenses, whose back surface consists of 4 or more zones with varying width and curvature ratios. These lenses are made from high oxygen-permeable materials (typically not lower than 100 units according to ISO/FATT). The refractive effect is associated with a decrease in epithelial thickness at the center and an increase in thickness in the mid-peripheral zone due to changes in the shape and size of superficial epithelial cells [185,186,187]. This leads to a flattening of the corneal center and an increase in its curvature in the mid-peripheral zone [177,178]. Uncorrected visual acuity improves as early as after the first night of lens wear and reaches its maximum within a period ranging from one week to one month [177,178].

Orthokeratology significantly slows down the progression of myopia or stabilizes it [153,176,180,181,182,183,184,185]. The technique is recognized as safe. Experimental and clinical studies have proven that effective inhibition of myopia progression and its stabilization are achieved by altering the eye's peripheral refraction with the formation of a peripheral myopic defocus [164,177].

The use of OKL helps increase the range of accommodation and accommodative amplitude to normal age-appropriate values, and these indicators remain stably high throughout the entire period of OKL use, while habitual excessive accommodation (TEA) does not develop. An improvement in dark adaptation time to normal values, an increase in reading speed by 19.9%, an improvement in visual productivity by 20.8%, an increase in the information throughput of the visual analyzer by 33%, and a 2.8-fold increase in the depth of the focal region for distance and 2-fold for near are also noted. This leads to a reduction in visual fatigue and an improvement in visual quality [178], which also contributes to the stabilization of the myopic process.

Indications for OKL prescription:

- Myopia up to -8.0 diopters

- Corneal astigmatism up to 5.0 diopters;

- Progressive myopia; with annual progression rate of more than 1.0 diopter per year combined with scleroplasty;

- Sports and other activities incompatible with spectacles and contact lens correction [177,178,179].

Absolute contraindications to orthokeratology lens (OKL) fitting:

- Inflammatory diseases of the eye, ocular adnexa, and orbit (acute conjunctivitis, acute and recurrent keratitis, scleritis, uveitis, acute and chronic dacryocystitis, blepharitis, meibomianitis, etc.).

- Severe dry eye disease

- Keratoconus, keratoglobus, and other corneal dystrophies

- Malignant neoplasms of the eye and its adnexa

- Decreased corneal sensitivity

- Lacrimal passage obstruction of any etiology

- Chalazion

- Lagophthalmus

- Pterygium, pinguecula

- Nystagmus

- Only seeing eye

- General acute infectious and inflammatory diseases

- Collagenoses, severe immunodeficiency states

- Isotretinoin intake (throughout the entire course of treatment)

- Inability to follow the physician's recommendations [179] and psychological characteristics that prevent safe use of OKL.

Relative contraindications to OKL fitting:

- Irregular astigmatism

- Corneal opacities and scar changes

- Oncological diseases, radiation therapy, and chemotherapy (until treatment is completed)

- Mild and moderate dry eye disease

- Tear film composition abnormalities

- Seasonal allergies

- Endocrine and autoimmune diseases

- Use of glucocorticosteroids.

Complications of orthokeratology correction:

- Complications typical of traditional contact lens wear

The procedure must be performed in specialized facilities and requires a high level of professional skill from an ophthalmologist, knowledge of the principles of the method, and skills in OKL fitting. Modern ophthalmic equipment, including a corneal topographer, is required for the procedure.

Prerequisites for the effective and safe application of the method are regular medical follow-up of patients and strict compliance by patients with lens use and care rules.

This type of correction is temporary, provides high visual acuity, and eliminates the need to wear glasses and contact lenses during the day [177,179,180,181,182,183,184,185].

OKL fitting in adults is possible.

3.2. Functional treatment

Comments: systematic impact on the accommodation apparatus for the purpose of preventing the onset and progression of myopia helps normalize accommodation tone, increase ciliary muscle performance, enhance the metabolic activity of ciliary body cells, and improve ocular hemodynamics [1,188,189,190].

Comments: 1) The "Mark on the Glass" exercise is performed wearing glasses, daily, once a day, for 1 month. For the first three days, the duration of each exercise – is 3 minutes; for the next three days – 5 minutes; on the remaining days – 7 minutes.

2) The exercise with a "Racket" or a home accommodotrainer is performed for 7–10 minutes for each eye with a 10-minute interval against the background of exercises for 4 weeks; patients are recommended instillation of #phenylephrine 2.5% solution, 1 drop at bedtime, to prevent the progression of true myopia in patients with high visual stress [1,192].

Comments:1). Special training glasses are used, containing optical elements in the form of aspherical lenses with zero (or other necessary) refraction in the geometric center, gradual enhancement of refraction on one side from the center and attenuation on the other. Such glasses can be made with a difference between the refraction in the center of the lens and at its periphery of ±0.25 D, ±0.5 D, ±0.75 D. The sum of the progression and regression values constitutes the magnitude of the dynamic change in the lens refraction. Thus, for a lens with a progression in one direction by 0.5 D and a regression in the other direction by 0.5 D from the geometric center, the change in lens refraction will be 1.0 D – the optimal value for training. When reading, conjugate eye movements force looking along the horizontal meridian of the aspherical lens, in which the refraction alternately and smoothly increases and decreases, causing alternating relaxation and tension of accommodation, exerting a training effect. When wearing such training glasses for two hours a day for 2 weeks, there is a decrease in refraction by an average of 0.21 D in myopia and 0.81 D in pseudomyopia, an increase in accommodative amplitude by 1.5 and 2.0 D, and RAR by 0.8 D and 1.1 D, respectively. Such a training effect helps reduce the risk of developing and progressing myopia. The glasses can be used for two or more hours a day during any visual load, throughout the entire period of risk of developing and progressing myopia [196].

2). Special spheroprismatic training glasses are used, providing a training effect based on the principles of divergent desaccommodation and micro-fogging. The exercises increase RAR by 0.4–0.6 D. The exercises are performed for 5–10 minutes in courses 2 times a year throughout the entire period of risk of myopia development [195].

Comments:

1). Accommodation training according to E.S. Avetisov and K.A. Mats is performed binocularly under full correction conditions, in the first 3 days – once a day, on the remaining days – twice a day. At very low starting values of the negative relative accommodation (NRA) / positive relative accommodation (PRA) volume, exercises are performed in a sparing mode: larger text is used for reading, the duration of exercises is shortened, and negative lenses from the trial lens set are changed with a step of 0.25 D. To refine submaximal loads, relative accommodation is determined every 3 days. The optimal criterion for the effectiveness of such training is an increase in RAR. The course consists of 15–20 training sessions. To consolidate the effect, it is recommended to perform the home exercises and training glasses sessions described above.

2). The optical micro-fogging method according to A.I. Dashevsky is performed for each eye separately. The duration of one training session is no more than 15 minutes for each eye. The course of treatment – 10 training sessions.

3). A.I. Dashevsky's divergent deaccommodation method. Prerequisite – stable binocular vision, contraindication – distance exophoria greater than 6.0 prism diopters.

4). The "rocking" method according to V.V. Volkov and L.N. Kolesnikova is used if it is not possible to achieve an increase in uncorrected visual acuity using the methods described above. Treatment is performed monocularly under conditions of full distance correction.

5). The method of combined application of a relaxing effect on the ciliary muscle using "glass atropine" or micro-fogging and divergent desaccommodation training is carried out using positive spherical and cylindrical lenses and prisms. Training can be performed automatically on special devices.

Accommodation training devices can be used from 3–4 years of age [191,192].

Comments: hardware treatment includes low-intensity laser stimulation of the ciliary muscle – transscleral non-contact exposure of the ciliary muscle using infrared laser radiation. 10 procedures are performed once or twice a day (in the latter case with a 30–40 minute break) 2–4 times a year.

Comments: it is advisable to use this method for its intended purpose – for the treatment of amblyopia. In progressive myopia, an increase in accommodation tone and even the development of a partial spasm of accommodation is possible after a course of training.

Comments: such training enhances dynamic eye refraction, increases the positive and negative relative accommodation, inducing a more rapid progression of myopia.

Comments: 1) Low-frequency magnetotherapy for the organ of vision and magnetophoresis of medicinal substances. The treatment course consists of 10 ten-minute procedures. 2) Electrophoresis of medicinal products for eye diseases is carried out according to three methods: on closed eyelids (Bourguignon method), through an electrophoretic bath on the open eye, and endonasally. 3) Electroacupuncture and electroacupuncture in reflexology are performed with direct current, the current strength is adjusted until a slight tingling or burning sensation appears at the site of exposure. The duration of exposure to each point is 1–2 minutes. When exposed to general points, a negative polarity current is used; for points in the eye area, a positive polarity current is used. The course of electroacupuncture includes 5–6 procedures, carried out 2–3 times a year. In rare cases, a transient increase in dynamic refraction is possible. 4) Reflexology for eye diseases. To treat myopia, general-action, local, paraorbital, collar zone, and auricular acupuncture points are used. The course of treatment consists of 10 procedures of 20 minutes each, performed daily or every other day. 5) Collar zone massage. It is recommended to perform 10 procedures 2 times a year.

Comments: for peripheral retinal dystrophies not predisposing to retinal detachment (peripheral cystoid degeneration, cobblestone degeneration, ora serrata pearls, pars plana cysts, white-without-pressure, white-with-pressure), physical education classes are permissible. The degree of myopia is not a decisive indicator when determining clearance for physical education classes [19,200].

3.3. Drug therapy

Comments: medical treatment with phenylephrine and tropicamide in combination with other drugs is used in the complex treatment of myopia along with optical correction and functional treatment. Medical treatment is usually carried out in courses 4 times a year at home, see Table 5

Comments: drugs with angioprotective and microcirculation-improving action for use in ophthalmology (antioxidant agents) and drugs that improve the functional state of the retina for systemic use in ophthalmology and multivitamins in combination with other minerals are prescribed in courses 2 times a year for home use. Medications used in the complex treatment of progressive myopia are presented in Table 5.

Table 5. Medications used in the complex treatment of progressive and complicated myopia

3.4. Surgical treatment

Comments: the main goal of treatment – the formation of adhesion of the retina with the pigment epithelium in the defect area. As a result of laser exposure during retinal photocoagulation, delicate pigmented chorioretinal scars are formed.

Comments: Scleroplasty is a pathogenetically substantiated method. During scleroplasty, graft materials are placed on the scleral surface (under Tenon's capsule), which are gradually replaced or invaded by newly formed connective tissue. As a result, a single sclera-graft complex is formed, which increases the biomechanical stability of the eye tunics and provides a stabilizing effect.

Various modifications of scleroplasty using donor or synthetic materials are used. Within one to two years after surgery, refraction stabilization is observed in 87%-96% of operated eyes and within one year in 80% of fellow eyes [220].

Comments: minimally invasive scleroplasty is characterized by a simple surgical technique and a minimal volume of intervention.

Comments: the modified Snyder-Thompson technique is low-traumatic, effectively stabilizes the myopic process, improves the trophism of the eye tunics, enhances visual functions, and prevents the development of disabling fundus complications. The operation uses a graft made of ophthalmic knitted polyester mesh or donor material formed as a strip 70 mm long and 10 mm wide. Scleral reinforcement can be performed using one of the modifications of the M.V. Zaikova technique, N.N. Pivovarov, or E.S. Avetisov – E.P. Tarutta.

Comments: the tactic and system of scleroplasty for progressive myopia in the most severe category of patients involves staged repeated scleral reinforcement in both eyes (Table 6).

Table 6. Staged schedule of scleroplasty.

Performing repeated scleroplasty in high-risk patients reduces the rate of myopia progression by an average of 4 times and ensures its long-term stabilization (up to 10 years) in 75% of cases, while reducing the incidence of chorioretinal dystrophic changes by 2.5 times [220].

Comments: to prevent the further development of staphyloma and damage to the Bruch's membrane–choriocapillaris–pigment epithelium complex, a low-traumatic technology of scleral reconstructive treatment for high complicated myopia is used, involving the creation of a local depression of the posterior pole sclera using an implant made of biologically active polyester mesh with a polymer coating.

The operation uses a graft formed as a strip 70 mm long and 10 mm wide (according to Snyder-Thompson). For local depression of the eye membranes in the posterior pole area, an implant measuring 10x15–20 mm is used, cut out from ophthalmic knitted polyester mesh or donor material and fixed to the middle part of the graft.

In the long-term postoperative follow-up period, persistent flattening of the staphyloma, restoration of the eye shape, improved trophism of its membranes, reduction of myopia degree and refraction stabilization, shortening and stabilization of APA length, increased scleral acoustic density, improved visual acuity, and stabilization of the fundus status and visual functions are maintained.

Comments: no conclusive evidence of the efficacy and safety of laser refractive surgery in children with myopia has been found. The main factors limiting the use of laser refractive surgery in childhood include incomplete refractogenesis, irreversibility of the refractive effect, its instability, the need for general anesthesia (which makes it difficult to center the treatment zone along the visual axis), and a number of other issues.

Expanding the indications for refractive surgery in children is premature and unjustified. For the widespread use of laser correction in pediatric practice, many issues regarding effect stability, safety, efficacy, and impact on refractogenesis remain to be resolved. Careful long-term research in large research centers over – 10 years or more is necessary.

Keratorefractive interventions are performed in patients aged 18 to 45 years with non-progressive (stationary) myopia from -0.5 to -12.0 D to achieve a predictable and stable refractive effect and high postoperative uncorrected visual acuity. Keratorefractive surgeries are an alternative method of vision correction in adults alongside glasses and contact lenses and are performed at the patient's request. The choice of a specific technique (PRK, LASIK, LASEK, Epi-LASIK, FemtoLASIK, RelexFlex, RelexSmile) depends on the following parameters: patient age, profession, engagement in certain sports, preoperative anatomical and topographic corneal parameters, anatomical features of the eye and orbit structure, healing characteristics, and peripheral retinal status [242, 243, 244, 245, 246, 247].

Intraocular correction—IOL implantation, including phakic IOLs—is performed in patients over 18 years of age with myopia greater than -12.0 D in cases where other correction methods are inapplicable or yield a significantly poorer refractive and functional outcome. The method is used to correct high-degree refractive errors and achieve high uncorrected visual acuity after surgical intervention [248,249]. In high myopia combined with astigmatism greater than 3.0 D, bioptics (a combination of phakic IOL implantation and excimer laser correction) may be used. Phacoemulsification with intraocular lens implantation is advisable at the age of over 40 years, as well as in the presence of lens opacities.

4. Medical Rehabilitation and Sanatorium-Resort Treatment

5. Prevention and Dispensary Observation

Comments: a decrease in the range of accommodation (ROA) below the minimum age-related values serves as a prognostic criterion for myopia progression. An increase in ROA values after treatment is a criterion for treatment efficacy and a favorable prognosis for the further course of myopia.

Detection of a positive accommodation reserve of more than 0.5 D in myopia is associated with a higher rate of myopia progression. A decrease in the accommodation reserve after treatment – is a criterion for treatment efficacy and a favorable prognosis for the further course of myopia [55].

Ultrasound criterion: Scleral acoustic density (SAD) – an informative indicator for predicting the nature of the further course of myopia, timely implementation of preventive measures, choice of treatment tactics, and indications for scleroplasty. SAD is evaluated by the amplitude of echo signal attenuation from the scleral capsule of the eye in the upper-temporal and lower-nasal quadrants of the equatorial zone and in the posterior pole of the eyeball.

- The normal SAD value for the equatorial zone is 46.0±0.24 dB;

- The normal SAD value in the region of the posterior pole of the eyeball is 47.6±0.2 dB;

- A decrease in SAD in myopia correlates with its degree, progression rate, and fundus condition;

- In eyes with uncomplicated myopia, the SAD in the equatorial zone is 40–48 dB;

- In eyes with myopia, an equator SAD of ≤ 39 dB is an unfavorable prognostic factor with a high probability of peripheral vitreochorioretinal degeneration (PVCRD) development;

- SAD measurement is used as an additional differential diagnostic study to select the method of scleral reinforcement: “major” or “minor” scleroplasty;

- Following “major” and “minor” scleroplasty, SAD increases: with “major” scleroplasty by 3.7 dB at the posterior pole and by 5.3 dB in the equatorial region; with “minor” scleroplasty, by 1.2 dB at the posterior pole and by 2.2 dB in the equatorial region. The change in SAD is statistically significant compared to the fellow eye and baseline level;

- In the long-term period after scleroplasty in eyes with continuing (or newly resumed) myopia progression, mean SAD values after both interventions not exceeding 41 dB at the posterior pole and 40 dB in the equatorial region serve as a criterion for the risk of further myopia progression and determination of indications for repeated scleral reinforcement [98,251].

No convincing evidence has been found regarding the use of dietary therapy for myopia in children and adults

6. Organization of Medical Care

Routine medical care is provided for myopia.

Primary pre-medical health care for adults with myopia is provided by medical opticians-optometrists.

Primary physician-delivered health care for children and adults with myopia is provided by ophthalmologists. An ophthalmologist at an ophthalmology office provides: consultative, diagnostic, and therapeutic care; dynamic observation; and, in the presence of medical indications, refers children to the children's vision protection office, and children and adults to specialized ophthalmological medical institutions and/or for inpatient medical care.

Upon suspicion or detection of signs of decreased vision in children and adults, pediatricians, district pediatricians, municipal (district) pediatricians, child and adolescent hygiene physicians, adolescent therapists, general practitioners (family doctors), district therapists, district occupational health therapists refer patients for a consultation with an ophthalmologist.

During routine medical examinations of minors, including upon admission to educational institutions and during the period of study, the ophthalmologist examines children at the age of 1 month, 12 months, 3 years, 6 years, 7 years, 10 years, 11 years, 15, 16, and 17 years.

The ophthalmologist examines adults with myopia during mandatory preliminary medical examinations (assessments) upon employment and periodic medical examinations (assessments) of workers engaged in work with harmful and (or) hazardous working conditions (including underground work), work related to the movement of transport, as well as workers of food industry organizations, public catering and trade, water supply facilities, medical organizations and childcare facilities, as well as certain other employers who undergo the specified medical examinations for the purpose of public health protection and the prevention of the occurrence and spread of diseases.

In the presence of progressive and/or complicated myopia, patients with myopia are referred for inpatient treatment to receive specialized medical care.

Indications for hospitalization in a day patient facility (day hospital) of a medical organization:

1) progressive myopia in children and adults, when indications for “minor” scleroplasty are identified and it cannot be performed in an outpatient setting;

2) progressive myopia in children and adults, when indications for functional treatment are identified and it cannot be performed in an outpatient setting;

3) complicated myopia in children and adults, when indications for laser barrier photocoagulation of the retina are identified and it cannot be performed in an outpatient setting;

Indications for hospitalization in a 24-hour inpatient facility (round-the-clock hospital) of a medical organization:

1) progressive myopia in children and adults, when indications for “major” scleroplasty are identified;

2) progressive myopia in children and adults, when indications for “minor” scleroplasty are identified and it cannot be performed in a day hospital or outpatient setting;

3) progressive myopia in children and adults, when indications for functional treatment are identified and it cannot be performed in an outpatient setting or in a day hospital setting;

4) complicated myopia in children and adults, when indications for laser barrier photocoagulation of the retina are identified and it cannot be performed in an outpatient setting or in a day hospital setting;

The basis for discharging a patient from a medical organization is the complete completion of the planned treatment.

7. Additional Information

Preventing the development of myopia is of particular importance, especially in preschool and early school age. Timely identification of myopia predictors [39,40,57] and active prevention of its early onset help reduce the incidence of high myopia and its complicated forms [39]. The most reliable predictors of myopia include: a cycloplegic spherical equivalent of axial refraction more hyperopic than +0.75 D in children under 6 years of age, an axial length greater than 23.5 mm with hyperopia $\le$+1.0 D, parental myopia, pseudomyopia, extra-axial refraction power of the nasal half of the eye at 20-30° higher than the temporal half in both eyes by more than 0.5 D, and physical inactivity combined with high visual workload [39,40,58,62,252]. Measures to prevent the early development of myopia include: compliance with the visual workload regimen—ergonomic stereotypes for near-vision work; creation of binocular central and peripheral myopic defocus—prescription of plus lenses inducing 0.75–1.0 D of myopia or transfocal spectacle lenses for vision correction with a central refraction of +0.25 D, the design of which allows them to be used for central vision correction and peripheral refractive reinforcement for continuous wear; home exercises for accommodation training, including the use of trainer glasses; physical education and sports; and spending at least 90 minutes a day outdoors during daylight hours [39,40,58,62,63,100,133,146,147,194,195,196,198].

Criteria for Evaluating the Quality of Medical Care

Criteria for assessing the quality of primary health care provided to children with myopia are presented in Table 7. Criteria for assessing the quality of specialized medical care provided to children with myopia are presented in Table 8. Criteria for assessing the quality of primary health care provided to adults with myopia are presented in Table 9. Criteria for assessing the quality of specialized medical care provided to adults with myopia are presented in Table 10.

Table 7. Criteria for assessing the quality of primary health care in children with myopia

Table 8. Criteria for assessing the quality of specialized medical care in children with myopia

Table 9. Criteria for assessing the quality of primary health care in adults with myopia

Table 10. Criteria for assessing the quality of specialized medical care in adults with myopia

References

Appendix A1. Working Group Composition

1. Brzheskiy Vladimir Vsevolodovich, MD, Prof., Association of Ophthalmologists LLC;

2. Vorontsova Tatyana Nikolaevna, PhD, Association of Ophthalmologists LLC;

3. Dogadova Lyudmila Petrovna, PhD, Association of Ophthalmologists LLC;

4. Zhukova Olga Vladimirovna, MD, Association of Ophthalmologists LLC;

5. Iomdina Elena Naumovna, Dr. Biol. Sci., Prof., Association of Ophthalmologists LLC;

6. Markova Elena Yuryevna, MD, Association of Ophthalmologists LLC;

7. Markosyan Gayane Aykazovna, MD, Association of Ophthalmologists LLC;

8. Milash Sergey Viktorovich, Physician, Association of Ophthalmologists LLC;

9. Proskurina Olga Vladimirovna, Dr. of Med. Sci., Association of Ophthalmologists LLC;

10. Saydasheva Elvira Irekovna, MD, Prof., Association of Ophthalmologists LLC;

11. Tarutta Elena Petrovna, Group Head, MD, Professor, Association of Ophthalmologists LLC;

12. Khodzabekyan Narine Vladimirovna, MD, Association of Ophthalmologists LLC

No conflict of interest is declared.

Appendix A2. Methodology for Developing Clinical Guidelines

The National Protocol for the Diagnosis and Treatment of Myopia in Children was developed taking into account the "Rules for the Provision of Medical Care to Children with Diseases of the Eye, its Adnexa and Orbit", approved by Order of the Russian Ministry of Health No. 442n dated October 25, 2012 (registered with the Russian Ministry of Justice on December 20, 2012, No. 26208), which sets out the basic provisions for the organization of pediatric ophthalmological care. Unlike the "Rules", which outline the main stages of providing ophthalmological care to children, the "Clinical Guidelines" are methodological recommendations for physicians that detail all stages of ophthalmological care and differentiated approaches in various situations, adhering to the principles of evidence-based medicine.

Methods used for evidence collection/selection: electronic database search; analysis of current scientific developments on the problem of childhood myopia in Russia and abroad; synthesis of the practical experience of Russian and foreign colleagues.

When selecting publications as potential sources of evidence, the methodology used in each study is examined to ensure its reliability. The result of this examination affects the level of evidence assigned to the publication, which in turn affects the strength of the recommendations derived from it.

A preliminary version of these guidelines was reviewed by independent experts who were asked to comment primarily on whether the interpretation of the evidence underlying the recommendations is reliable and accessible to practicing physicians and patients.

Feedback has been received from ophthalmologists specializing in myopia and primary care physicians regarding the clarity of presentation and the importance of the recommendations as a practical tool for everyday medical practice.

Comments received from experts were carefully systematized and discussed by the chairs and members of the working group. Every item was discussed. Changes and additions recommended as a result of the discussion were incorporated into the text of the guidelines.

Target audience for these clinical guidelines:

1. Ophthalmologists;

2. General practitioners (family physicians);

3. District general practitioners;

4. District general practitioners

5. Pediatricians;

6. Urban (district) pediatricians;

7. District pediatricians;

8. Adolescent general practitioners

9. Child and adolescent hygiene physicians;

10. Physiotherapists;

11. Medical opticians-optometrists

Table 1. Levels of Evidence (LoE) grading scale for diagnostic methods (diagnostic interventions)

Table 2. Scale for grading levels of evidence (LE) for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)

Table 3. Scale for grading grades of recommendation (GR) for prevention, diagnostic, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, and rehabilitative interventions)

Procedure for updating clinical guidelines

The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data on the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.

Appendix A3. Reference Materials

These clinical guidelines were developed taking into account the following regulatory legal documents:

1. Order of the Ministry of Health of the Russian Federation No. 442n dated October 25, 2012 "On Approval of the Rules for the Provision of Medical Care to Children with Diseases of the Eye, its Adnexa and Orbit" (as amended on July 27, 2020)

2. Order of the Ministry of Health of the Russian Federation No. 902n dated November 12, 2012 "On Approval of the Rules for the Provision of Medical Care to Adults with Diseases of the Eye, its Adnexa and Orbit" (as amended on February 1, 2022)

3. Order of the Ministry of Health of the Russian Federation No. 567n dated June 2, 2021 "On Approval of the Standard of Medical Care for Children with Myopia (Diagnosis, Treatment, and Follow-up Care)".

4. Order of the Ministry of Health of the Russian Federation No. 203n dated May 10, 2017 "On Approval of Criteria for Assessing the Quality of Medical Care"

5. Decree of the Government of the Russian Federation No. 2406-r dated October 12, 2019

6. State Register of Medicines (as of August 30, 2024)

7. Order of the Ministry of Health of the Russian Federation No. 514n dated August 10, 2017 "On the Procedure for Conducting Preventive Medical Examinations of Minors" (as amended on November 19, 2020).

8. Order of the Russian Ministry of Health No. 29n dated January 28, 2021 "On Approval of the Procedure for Conducting Mandatory Preliminary and Periodic Medical Examinations of Employees Provided for in Part Four of Article 213 of the Labor Code of the Russian Federation, the List of Medical Contraindications to Performing Work with Harmful and (or) Hazardous Production Factors, as well as Work Requiring Mandatory Preliminary and Periodic Medical Examinations"

9. Order of the Ministry of Health of the Russian Federation No. 909n dated November 12, 2012 "On Approval of the Rules for the Provision of Medical Care to Children in the Field of 'Anesthesiology and Reanimatology'" (as amended on July 9, 2013).

10. Order of the Ministry of Health of the Russian Federation No. 919n dated November 15, 2012 "On Approval of the Rules for the Provision of Medical Care to Adults in the Field of 'Anesthesiology and Reanimatology'" (as amended on September 14, 2018)

11. GOST 30808-2002 Spectacle Lenses. General Specifications.

12. Federal Law of the Russian Federation No. 323-FZ dated November 21, 2011 "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation".

Table 1. Drugs used for the diagnosis of myopia

Table 2. Drugs used in the complex treatment of progressive and complicated myopia

Appendix B. Physician Action Algorithms

Myopia

Appendix C. Patient Information

Myopia is the most common optical defect. In a myopic eye, light rays are refracted more than necessary, with the result that the image is formed not on the retina (the light-sensitive structure of the eye), but in front of it, making it unclear and blurred. Over the past 20 years, the prevalence of myopia has increased catastrophically worldwide. Among young people in the US and Europe, it reaches 40-45%. In our country, it is observed in 30% of school graduates, and in gymnasiums and lyceums this figure approaches 50%. It is hard not to notice that in the most computerized and fast-learning region of the world—Southeast Asia (Taiwan, Hong Kong, Singapore)—the prevalence of myopia exceeds 70%. And such a "surge" in incidence cannot be blamed solely on heredity, as this contradicts the laws of genetics. Clearly, various environmental factors make a harmful contribution. These include early increased visual load, various electronic media devices, gaming devices, and a sedentary lifestyle among children—where are you, our noisy and long outdoor games? A certain role in this is played by general health, which corresponds to the norm in at best 10% of children, as well as poor ecology. As you can see, there are many factors, both external and internal, but in order to lead to the development of myopia, they must be mediated through some substrate within the eye itself. And this substrate is weakened accommodation—an adaptive mechanism that allows a healthy person to see clearly at any distance, both far and near. It was precisely accommodation disorders that were identified as the "weak link" in the origin of myopia by Professor E.S. Avetisov almost 60 years ago.

To prevent the development of myopia, specialists at the Helmholtz National Medical Research Center of Eye Diseases developed the method of "constant mild myopic defocus" using specially selected glasses. Children at high risk of developing myopia (especially children of myopic parents), with signs of "pre-myopia," or with early myopia are prescribed glasses for continuous wear (in the first case, corrective glasses with positive lenses; in the second case, alternating daily between corrective glasses with positive lenses for one eye and corrective glasses with weak negative lenses for the other) so as to create a mild myopic defocus in the eye. The power of the lenses is calculated and selected individually to ensure adequate distance visual acuity for life and study. Another optical method for correction and control of mild and moderate myopia progression is glasses that form peripheral myopic defocus for continuous wear.

An effective method for controlling the progression of myopia—nocturnal orthokeratology correction—was developed in the USA, but quickly spread worldwide and has been used for over 15 years at the Helmholtz National Medical Research Center and other clinics in Russia. Literally translated, "orthokeratology" means "correction of the cornea." In reality, these lenses help to "tailor" the shape and refractive power of the cornea to the existing degree of myopia so that the "hyperopic" cornea corrects the myopia caused by excessive eye length. This is achieved through a special, complex lens shape that exerts a planned, dosed effect on the anterior surface of the cornea overnight, predominantly on its epithelial layer. The result of this effect persists throughout the day and is maintained again by the lens at night, allowing patients to go without any correction during the day and have a visual acuity close to or equal to 100%. The result itself is excellent, allowing for sports and other active pursuits. In addition, orthokeratology slows down the progression of myopia. Of course, children must be monitored: an ultrasound examination is necessary to assess myopia progression via changes in eye length, as well as corneal microscopy to detect potential complications before their clinical manifestation. If myopia progression is detected, orthokeratology can be combined with other types of stabilizing treatment: hardware-based, pharmacological, and/or surgical. If, after reaching 18–20 years of age with stable myopia, the patient wishes to stop wearing orthokeratology lenses and undergo corrective surgery, nothing will prevent them from doing so. They simply need to stop using the lenses, wait under a doctor's supervision for their myopia to return, and then correct it using one of the existing laser surgical methods.

In addition to optical methods, hardware-based treatment methods are widely used for treating progressive myopia. A comprehensive program of hardware treatment for myopia is effective, including laser stimulation of the ciliary zone, optic-reflex training, magnetophoresis, acupuncture, and collar-zone massage. After treatment, the tonus and functional capacity of the ciliary muscle normalize, ocular hemodynamics improves, and the rate of myopia progression slows down.

However, not all children achieve halted myopia progression. In some cases, despite optical methods and hardware treatment, myopia continues to progress. In these cases, scleroplasty is used. Techniques for major and minor scleroplasty have been developed. Minor scleroplasty reinforces the most compliant supero-external area of the sclera. A synthetic material is used for minor scleroplasty. Major scleroplasty is performed for high myopia with a rapid rate of progression and involves reinforcing the posterior pole of the sclera.

If a child is diagnosed with myopia or is at risk for developing myopia, ophthalmological monitoring is required at least once every 6 months.

Adults with progressive myopia require ophthalmological monitoring at least once every 6 months, and those with stable myopia, once a year.

Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools

Not used.