Complicated cataract: clinical guidelines

List of Abbreviations

AGO — antiglaucomatous operation

ATP synthase — adenosine triphosphate synthase

IOP — intraocular pressure

AMD — age-related macular degeneration

GCS — glucocorticosteroids

YAG — yttrium-aluminum-garnet (YAG laser)

IOL — intraocular lens

ICC — intracapsular cataract extraction

CTR — capsular tension ring

CBR — ciliary block glaucoma

CME — cystoid macular edema

LEC — laser cataract extraction

ICD-10 — International Statistical Classification of Diseases and Related Health Problems 10th Revision

BCVA — best corrected visual acuity

UCVA — uncorrected visual acuity

NSAIDs — nonsteroidal anti-inflammatory drugs

OCT — optical coherence tomography

PVI** — povidone-iodine**

POAG — primary open-angle glaucoma

PES — pseudoexfoliation syndrome

RSP-3 — collagen copolymer intraocular lens for extra-capsular fixation

RF — Russian Federation

UV rays — ultraviolet rays

Femto-CE — femtosecond-assisted cataract extraction

Phaco — phacoemulsification of cataract

CE — cataract extraction

ECCE — extracapsular cataract extraction

Terms and Definitions

Viscoelastics are special polymer solutions used to protect the corneal endothelium and maintain anterior chamber volume during anterior segment surgery.

Intracapsular cataract extraction (ICCE) is a surgical method of cataract treatment consisting of the removal of the lens together with the capsular bag.

Laser cataract extraction (LCE) is a method of fragmenting the lens substance inside the capsular bag using laser energy followed by aspiration of the resulting fragments.

Phacoemulsification of cataract (Phaco) is a surgical method of cataract treatment consisting of ultrasonic fragmentation of the lens nucleus inside the capsular bag and its aspiration followed by implantation of an intraocular lens (IOL).

Femtosecond-assisted phacoemulsification (Femto-Phaco) involves a two-stage procedure: the first stage uses a femtosecond laser to create corneal incisions, perform capsulotomy, and fragment the nucleus, while the second stage involves the evacuation of the lens substance and subsequent IOL implantation.

Phakic IOL is an IOL implanted into the posterior chamber of the eye in front of the natural lens or fixed to the iris to correct high refractive errors in patients under 40 years of age.

Extracapsular cataract extraction (ECCE) is a surgical method of cataract treatment consisting of the mechanical removal of the lens nucleus from the capsular bag either entirely or in parts, requiring a large incision (from 6.0 mm wide) and subsequent suture closure.

Optical coherence tomography is a non-invasive imaging method that allows visualization of anterior and posterior segment structures of the eyeball with high resolution (up to 5 µm) and their quantitative measurement.

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Complicated cataract is a pathological condition associated with partial or complete opacification of the lens, which develops against the background of concomitant ophthalmic or general somatic pathology and manifests with various degrees of visual impairment up to the complete loss of form vision.

Lens dislocation is a pathological condition associated with the complete detachment of the lens from the suspensory ligament and its displacement into the anterior or posterior chamber of the eye, accompanied by a sharp decrease in visual acuity.

Aphakia is the congenital or acquired absence of the natural lens of the eye.

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

Changes occurring in other structures of the eyeball or general somatic pathology exert a negative impact on the highly vulnerable metabolic processes within the lens. Severe recurrent inflammatory eye diseases and dystrophic processes are accompanied by alterations in the composition of intraocular fluid, which lead to impaired lens metabolism. Complicated cataract develops in recurrent iridocyclitis, chorioretinitis, dystrophies of the iris and ciliary body (Fuchs syndrome), glaucoma, myopia, hyperopia, vitreoretinal pathology, and pseudoexfoliation syndrome [1, 148].

The most common risk factors for cataract development include diabetes mellitus, prolonged use of topical, systemic, or inhaled glucocorticosteroids, and previous intraocular surgery. Most studies on cataract risk factors are observational, suggesting associations but unable to reliably prove causal relationships because they do not study cataract progression or risk factor exposure in a standardized manner [129, 130, 133].

It should be noted that the term "complicated cataract" indicates not only the severity of the eye pathology, but also points to the difficulties that may arise during surgery and the unpredictability of the functional outcome [132].

Factors complicating cataract surgery include [132, 148]:

- Presence of concomitant pathology (glaucoma, endothelial-epithelial corneal dystrophy, etc.);

- Anatomical and topographical features of the eye;

- High and moderate refractive errors;

- Pseudoexfoliation syndrome;

- Presence of optical media opacities;

- Previous surgical interventions on the eyeball (avitria, etc.);

- History of inflammatory eye diseases;

- Presence of severe concomitant somatic pathology (diabetes mellitus, bronchial asthma, atrial fibrillation).

Pathogenesis

According to a number of authors, changes in the composition of the aqueous humor of the anterior chamber with the formation of abnormal metabolites lead to the destruction of lens fiber proteins. It has also been established that cataract is accompanied by changes in the trace element and amino acid composition of the lens, accumulation of sodium, calcium, zinc, and water in its tissues, and a decrease in potassium, aluminum, soluble proteins, sulfur-containing amino acids, related crystallins, ascorbic acid, riboflavin, and cytochrome. The activity of ATP synthase, pyruvate phosphokinase, carbonic anhydrase, etc., is reduced. The question of what triggers such changes still remains open [1, 149].

Changes occurring in other tissues of the eye or general body pathology can affect the metabolic processes in the lens. Recurrent inflammatory eye diseases and dystrophic processes are accompanied by a change in the composition of intraocular fluid, which in turn leads to impaired metabolic processes in the lens and the development of opacities. As a complication of the primary eye disease, cataract develops in recurrent iridocyclitis and chorioretinitis of various etiologies, advanced terminal glaucoma, etc.

Cataract can occur in endocrine pathology, with diabetic cataract being most commonly observed in clinical practice. It develops in severe courses of the disease at any age and is more often bilateral [133, 134].

The lens is highly sensitive to all adverse environmental factors, whether mechanical, chemical, thermal, or radiation exposure.

Post-traumatic changes in the lens can manifest not only as opacification, but also as displacement of the lens (luxation or subluxation) as a result of complete or partial rupture of the zonular fibers.

Disruption of the lens zonular apparatus results in its displacement—ectopia, which is accompanied by anatomical and topographical changes in the structure of the anterior segment of the eye [135-137]. Patients with lens subluxation belong to a difficult category of patients, determined not only by the clinical presentation, but also by the significant risk of intraoperative (posterior capsule rupture, vitreous loss, etc.) and postoperative (secondary glaucoma, retinal detachment, iridocyclitis, etc.) complications, as well as unsatisfactory treatment outcomes [138].

Lens subluxation occurs due to defects or stretching of the zonular fibers developing under the influence of various factors. Lens dislocations can be congenital or acquired, traumatic or spontaneous [138]. Spontaneous lens displacements against the background of cataract are usually caused by inflammatory or age-related degenerative changes in the zonular fibers. Insufficiency of the lens zonules can be localized or extensive. Eye trauma or congenital defects can lead to localized damage to the zonular fibers. Systemic diseases such as Marfan syndrome, pseudoexfoliation syndrome (PES), and others can cause extensive changes in other eye structures as well [135]. PES is noted as the most frequent cause (up to 50% of cases) of zonular weakness, leading to progressive degradation resulting in phacodonesis and lens subluxation, as well as late pseudophacodonesis and IOL dislocation [139, 142, 140, 143].

Glaucoma [141], high myopia, trauma, uveitis, diabetes mellitus, and other conditions are also frequently noted as risk factors for weakening of the lens zonular apparatus that affect the results of phaco and the stable position of the IOL [144, 145].

Complicated cataract in high myopia occurs in 15-55% of cases and develops in patients 10 years earlier than senile cataract [50, 53]. The frequent development of myopic cataract in working-age individuals [15] under the conditions of modern society, which places high demands on the quality of visual functions, determines the social significance of this pathology and the relevance of finding effective and safe methods for the treatment and prevention of the disease and its complications [12].

Uveal cataract is observed in 8–78% of patients with inflammatory diseases of the uveal tract, most frequently in anterior uveitis [128].

Several mechanisms are considered in the pathogenesis of uveal cataract: autoimmune mechanism, increased permeability of the blood-ocular barrier with the accumulation of lysolecithin [7], macrophages, the role of free-radical oxidation [16], as well as corticosteroids used long-term in the treatment of uveitis [128, 146].

Pseudoexfoliation syndrome (PES) is a significant risk factor for cataract development, and its manifestations create an unfavorable "background" that worsens its course, surgical treatment, and outcome [139, 140].

1.3 Epidemiology of the Disease or Condition

Cataract is the most common cause of preventable blindness in the world, diagnosed in 60–90% of people aged 50–60 years. The prevalence of cataract in the Russian Federation based on the treatment-seeking criterion is 1,201.5 per 100,000 population [36, 41, 147].

In the only population-based study to date in the Russian Federation dedicated to the prevalence of visual impairment from cataract, performed according to the international RAAB (Rapid Assessment of Avoidable Blindness) standard and based on cluster sampling of a randomized population (amounting to 4,044 individuals per 336,000 population aged over 50 years), visual reduction from cataract to 0.3 and below occurred in 8.69% of those examined. At the same time, cataract was diagnosed 2 times more often in women than in men [2].

Currently, in the Russian Federation, the diagnosis of cataract is established in 1,200 people per 100,000 population, which collectively gives a total number of patients with lens opacification equal to approximately 1,750,000. Considering the number of annual cataract extraction surgeries (460,000–480,000), it should be stated that the need for surgical treatment is met by only 1/3 to 1/4. This indicator varies widely among the regions of the Russian Federation, as the fact of greater availability of surgical care for patients living in cities and large settlements, as opposed to rural residents, is obvious [3].

Congenital aphakia is classified among orphan diseases; its incidence in the population has not been sufficiently studied. At the same time, the number of postoperative aphakias resulting from cataract extraction is increasing every year. The risk of developing the acquired form of the disease increases sharply after the age of 40. An increase in the number of acquired forms of the disease is projected in economically developed countries.

Cataract is one of the main causes of low vision and reversible blindness worldwide, while lens subluxation and dislocation occur in 5–15% of cases in the general population of patients with cataract [216].

1.4 Features of Coding the Disease or Condition

H26.0 — Infantile, juvenile and presenile cataract

H26.1 — Traumatic cataract

H26.2 — Complicated cataract

H26.3 — Drug-induced cataract

H26.8 — Other specified cataract

H26.9 — Cataract, unspecified

H27.0 — Aphakia

H27.1 — Dislocation of lens

H27.8 — Other specified disorders of lens

H28.0* — Diabetic cataract (E10-E14+ with common fourth character .3)

T85.2 — Mechanical complication of intraocular lens

1.5 Classification of the disease or condition

Classification of complicated cataract depending on the localization of opacities in the lens substance [4]:

1. nuclear cataract;

2. cortical cataract;

3. posterior subcapsular cataract;

4. total (complete) cataract.

Classification of traumatic cataract depending on the nature of the traumatic impact:

1. Traumatic cataract after penetrating wounds of the eyeball;

2. Traumatic cataract after blunt trauma to the eyeball.

Classification of aphakia depending on etiology:

1. Congenital aphakia;

2. Acquired aphakia:

   - postoperative

   - post-traumatic

Classification of lens dislocation depending on its position [4]:

1. Dislocation into the anterior chamber;

2. Dislocation into the vitreous body:

   - fixed — the lens is immobile, fixed by adhesions to the retina, optic disc, ciliary body;

   - mobile — the lens moves freely within the vitreous body; in the patient's sitting or standing position, the lens is located in the lower part of the vitreal cavity. In the supine position, the lens moves toward the optic disc;

   - migratory — the lens is highly mobile, can move from the vitreal cavity into the anterior chamber and back.

1.6 Clinical presentation of the disease or condition

A distinct clinical picture in complicated cataract is determined not only by the characteristic lesion of the lens but also by the presence of changes in the anterior and/or posterior segment of the eye associated with the underlying process. In cataracts against the background of iridocyclitis and uveitis, synechiae are observed, deforming the pupil and leading to circular fusion of the pupillary margin with the anterior capsule or occlusion of the pupil.

During slit-lamp examination, one can note the presence of pseudoexfoliations along the pupillary margin and on the anterior lens capsule, which is often associated with the inability to achieve maximal mydriasis. The earliest clinical sign of PES is pigment dispersion. The dusting of pigment over the structures of the anterior segment of the eye occurs before the appearance of exfoliation material in the clinically accessible zones [62, 81]. Upon careful biomicroscopy of the eye over the entire surface of the anterior lens capsule until the formation of typical PE material deposits, a diffuse matte homogenous film consisting of a layer of microfibrils can be observed. Gradually, the precapsular layer becomes thicker; during iris excursions, focal defects form in the mid-peripheral zone of the anterior lens capsule (ALC), starting most frequently from the upper nasal quadrant ("mini-PES"), subsequently increasing, merging, and forming the classical picture of manifesting PES [52]. Upon examination, lens opacities of varying severity are visualized.

True diabetic cataract in its typical form is more common in young people with juvenile uncompensated diabetes. Such cataracts can develop very rapidly, within a few days [48]. It is characterized by early refraction changes, usually toward myopia. As a rule, such cataracts are bilateral. The biomicroscopical picture of diabetic cataract is very characteristic: white punctate or flaky opacities (“snowflakes”) arise subcapsularly in the superficial layers of the anterior and posterior cortex, as well as subcapsular vacuoles, which can also be found deep in the cortex, where water clefts, visible in retroillumination as optical irregularities, also form.

As the cataract "matures," deeper gray cloud-like opacities appear, after which the entire lens becomes uniformly opaque, and the cataract loses its characteristic appearance, becoming indistinguishable from cataracts of other genesis.

Diabetic cataract may not have the classical biomicroscopical picture and in some cases manifests as a regular complicated cataract with vacuoles and peripheral cortical opacities in the central part of the lens.

Senile cataract in diabetic patients has a number of features determined by the underlying disease. In particular, it develops at a younger age than ordinary senile cataract and is more frequently bilateral. There is evidence that such cataracts "mature" in a shorter period [48, 150]. Brown nuclear cataract with a large nucleus and a small amount of lens masses is often present. Such a cataract differs even in the early stage by a significant shift in refraction toward myopia. However, predominantly cortical, posterior subcapsular, and diffuse lens opacities are also possible. About 20% of patients present at the mature cataract stage, clinically indistinguishable from ordinary senile cataract.

Lens changes in diabetic patients are always accompanied by dystrophic changes in the iris, which can be detected by biomicroscopy of the eye [4, 150].

Traumatic lens opacities include local (punctate, disseminated, zonular, rosette-like, stellate) or diffuse cataractous opacities. Similar to penetrating wounds, blunt injuries involving the lens are classified among the most severe due to the extent and depth of damage to other structures of the eyeball.

Several degrees of lens dislocation are distinguished:

1. First-degree subluxation (the lens has no lateral displacement relative to the optical axis of the eye, but minor displacements along the optical axis are possible; iridodonesis, a decrease or increase in the depth of the anterior chamber are observed; fibers of the zonule of Zinn are partially ruptured).

2. Second-degree subluxation (the lens has a lateral displacement toward the preserved zonular fibers; with their significant rupture, the equator of the lens can be seen even with a narrow pupil; uneven deepening of the anterior chamber, pronounced iridophacodonesis, and myopic refraction are observed, as light rays pass through the peripheral parts of the lens).

3. Third-degree subluxation (the zonule of Zinn is ruptured by more than half of its circumference, the edge of the lens is displaced beyond the optical axis, significantly tilting into the vitreous body; aphakic refraction is observed).

4. Dislocation into the anterior chamber (changes in the cornea, iris, anterior chamber angle, sharp rise in intraocular pressure due to pupillary block and anterior chamber angle block or local irritation of the ciliary processes, rapid loss of visual functions).

5. Dislocation into the vitreous body (distinguished as mobile lens, moving within the vitreous body; migrating, moving from the vitreous body into the anterior chamber and back; fixed by adhesions to the retina, optic disc, ciliary body, in the center of the vitreal cavity).

Thus, lens injuries in eyeball trauma are characterized by extreme polymorphism of clinical manifestations and, as a rule, are combined with damage to surrounding structures.

When examining an aphakic eye with a slit lamp, a deep anterior chamber and trembling of the iris (iridodonesis) are noteworthy. If the posterior lens capsule is preserved in the eye, it restrains the shocks of the vitreous body during eye movements, and iris trembling is significantly weaker. During biomicroscopy of the eye, the light section reveals the location of the capsule, as well as the degree of its transparency. There is a corneal or limbal scar at the site of the performed surgery; post-traumatic corneal or corneoscleral scars of various configurations and extents with or without sutures may be present. There is an irregular shape of the pupil; the optical section of the lens is not determined. Remnants of the capsule or lens substance may be present in the pupillary area.

In the absence of the lens capsular bag, the vitreous body, held only by the anterior hyaloid membrane, is pressed against the iris and slightly protrudes into the pupillary area (vitreous hernia).

The clinical picture of an ectopic lens depends on the severity of the injury; along with well-known signs of lens displacement, such as iridodonesis, unevenness of the anterior chamber angle, changes in the clearance between the iris and the lens and displacement of the anteroposterior axis of the lens are noteworthy. A reliable frequent symptom is a vitreous hernia and its presence in the anterior chamber.

Traumatic dislocations are characterized by damage to the iris in the form of tears and ruptures of the pupillary margin, iridodialysis, etc.

2. Diagnostics, medical indications and contraindications for diagnostic methods

2.1 Complaints and Anamnesis

Comments: blurred vision followed by its decrease are characteristic symptoms of lens opacity; however, similar complaints can also occur with other eye pathologies. The impact of cataract on visual functions can be subjectively assessed based on the patient's description of their functional capabilities and vision problems. Over time, patients adapt to low vision and may not notice the gradual decrease in visual functions and the progression of cataract. Anamnestic data collection includes assessing the timing and rate of visual impairment, the patient's subjective description of their visual and functional capabilities, general health status, medications taken, a history of trauma, and other risk factors that may affect the course and outcome of surgery (immunodeficiency states, systemic use of alpha-1 blockers (C02CA), diabetes mellitus, allergies, etc.).

During the initial examination of a patient with cataract, one should:

• determine the etiology of the process taking into account concomitant risk factors;

• identify concomitant and systemic diseases that can lead to vision loss or affect the progression of the disease, the course of surgical intervention, the postoperative period, or the final treatment outcome;

• determine indications and contraindications for surgery; establish the optimal treatment tactics;

• evaluate the prognosis for the restoration of visual functions in the postoperative period.

2.2 Physical Examination

2.3 Laboratory Diagnostics

Specific laboratory diagnostics for complicated cataract are not used.

2.4 Instrumental Diagnostics

Comments: includes examination of the eyelids, eyelashes, lacrimal drainage system, orbit, position of the eyeballs and assessment of their mobility.

• For all patients with complicated cataract, it is recommended to perform biomicroscopy of the anterior segment of the eye using a slit lamp under natural conditions and under conditions of mydriasis to assess the condition of the eye, identify complicating factors and concomitant eye pathology [121, 122, 157, 158].

GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)

Comments: the main method is optical biometry, which can be based on laser optical interferometry or optical low-coherence reflectometry using a superluminescent diode. Both are comparable in accuracy [8]. The ultrasound biometry method yields a greater error; the need for it arises when the optical method cannot be used (mature cataract, dense opacities of the posterior lens capsule).

Comments: manual and automated keratometers, autorefractometers and keratometers built into optical biometers are used for keratometry. In controversial cases, to clarify the type, axes, and degree of corneal astigmatism, keratotopography (based on the principle of using a Placido disc) or optical coherence tomography of the cornea is used.

2.5 Other Procedures

Comments: in the majority of patients, an ophthalmologist can determine the contribution of cataract to the reduction of visual functions by comparing the results of biomicroscopy of the eye with the patient's specific symptoms.

Sometimes a patient's visual symptoms are disproportionate to the severity of the cataract. Relying solely on visual acuity assessment does not allow for a quantitative evaluation of certain visual symptoms, such as decreased glare resistance and loss of contrast sensitivity. Testing in a dark room with high contrast and a brightly lit object may significantly underestimate the functional problems experienced by the patient under various lighting and contrast conditions.

Wavefront analysis has shown that even minor cataracts can cause a significant increase in optical aberrations. Normally, the natural negative spherical aberrations of the lens are compensated by the natural positive spherical aberrations of the cornea. In cataract, the aberrations of the lens shift toward the positive side, disrupting the established balance and leading to decreased contrast sensitivity. In some cases, this explains the pronounced complaints of certain patients with mild lens opacities and relatively high best-corrected visual acuity [6].

Comment: these studies are prescribed for patients with corneal pathology to determine the risk of posterior endothelial decompensation and corneal opacity, as well as following eye trauma or previous surgeries.

Comment: these studies are performed in patients with concomitant retinal pathology (age-related macular degeneration (AMD), epiretinal fibrosis, high myopia, glaucoma, etc.) to determine the risk of progression of this pathology and its impact on postoperative visual functions.

Comment: ultrasound scan of the anterior segment of the eye (ultrasound biomicroscopy) is an effective method for assessing the degree of damage to the zonule of Zinn, allowing determination of the upcoming surgical treatment strategy for patients [36, 13, 32, 11].

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

3.1. Conservative management

Conservative treatment of complicated cataract is ineffective. To date, there are no known medications that can cure cataract or slow its progression.

3.2. Surgical treatment

Comments: among the variety of surgical procedures, phacoemulsification with intraocular lens implantation (A16.26.093.002) has become the most widely used at the present stage.

Comments: it should be noted that there is a lack of universal and generally accepted diagnostic methods that allow correlating the state of visual functions with the patient's quality of life, work capacity impairment, and ability to perform routine daily activities.

• Surgical treatment of cataract is recommended for patients with a decrease in visual functions leading to a restriction of work capacity, which no longer satisfies their needs for visual acuity and the absence of abnormal visual phenomena, and creates discomfort in daily life [17, 18, 118].

GCR BLEL 3Grade of Recommendation B (Level of Evidence – 3)

Comments: in modern conditions, when patients have increased demands for quality of life and do not accept the need for functional limitations associated with vision loss, there are justified prerequisites for expanding indications and earlier cataract surgery. The current stage of development of surgical technologies justifies the introduction into clinical practice of a conventional threshold equal to the loss of central vision down to 0.5 with correction.

Indications for surgical treatment of complicated cataract are:

• decrease in visual acuity due to lens opacity;

• clinically significant anisometropia associated with cataract;

• lens opacities impeding the diagnosis and/or treatment of posterior segment eye diseases;

• intraocular pressure disturbances associated with cataract development (phacomorphic, phacolytic, phacotopic glaucomas);

Relative contraindications to surgical intervention for complicated cataract are:

• level of corrected visual acuity in the affected eye that meets the patient's needs;

• presence of comorbid psychosomatic pathology in the patient that does not guarantee safe surgical intervention;

• lack of instrumental base, equipment, consumables, or anesthetic support in the medical facility, preventing safe execution of the surgical scope;

• lack of conditions for adequate postoperative care of the patient and administration of appropriate postoperative treatment.

Absolute contraindications to surgical intervention for cataract can be considered situations where the surgeon does not expect an improvement in visual functions as a result of surgery and there are no other medical indications for cataract removal (phacogenic pathology).

It should be emphasized that in real-world clinical practice, every patient requires an individualized approach. The attending physician (surgeon) must make the final decision on the appropriateness and adequacy of choosing surgical treatment, taking into account all aspects of the patient's local and systemic status.

Preoperative medical examination

Surgeon's responsibilities:

• obtain informed consent signed by the patient or an authorized representative;

  • ensure the necessary scope of preoperative examination of the patient (see the "Ophthalmological Examination" section); make sure that the medical documentation accurately reflects the symptoms, clinical features, and indications for treatment;

  • conduct a discussion and explain the risks, benefits, expected outcomes of surgical treatment, including the expected refractive outcome and surgical experience;

  • discuss the results of the preoperative examination with the patient or an authorized representative;

  • determine the scope of surgical intervention and select an appropriate IOL;

  • determine and discuss with the patient or an authorized representative the postoperative management strategy (drug regimen, care specifics, caregivers);

  • answer the patient's questions about the upcoming surgery and the postoperative period, including necessary expenses.

• For all patients requiring replacement of a clouded crystalline lens or correction of ametropia while preserving the lens zonular apparatus and capsular bag, lens extraction (A16.26.092) (extracapsular cataract extraction [ECCE]) is recommended. The preferred and most widely used variant of ECCE is phacoemulsification with intraocular lens implantation (A16.26.093.002) [17, 18, 172, 173].

GDR CLE 5Grade of recommendation C (level of evidence – 5)

Comments: to prevent the development of secondary cataract, performing a posterior capsulorhexis can be one of the surgical steps [210].

• All patients are recommended topical application of #povidone-iodine** (PVP**) as the primary form of prophylaxis for acute postoperative bacterial endophthalmitis (hereinafter — APBE) during cataract surgery. A mandatory step aimed at reducing the bacterial load in the wound area involves applying 7.5% or 10% #povidone-iodine** topical and external solution to the cornea, conjunctival sac, and periocular skin at least 3 minutes before surgery. In cases where #povidone-iodine** is contraindicated (true allergy is rare, and hyperthyroidism is only a relative contraindication to this single-use application), 0.05% #chlorhexidine** topical and external solution (aqueous) can be used [25].

GDR CLE 5Grade of recommendation C (level of evidence – 5)

Comments: literature data support the use of #povidone-iodine** (PVP**) as the primary preoperative preparation agent with proven efficacy [25].

The results of a prospective randomized study involving 132 adult patients (87 women, 45 men) demonstrated the benefits of combined antibiotic prophylaxis using topical #povidone-iodine** (PVP**) topical and external solution (applied to the cornea, conjunctival sac, and periocular skin) combined with instillation of #levofloxacin** 0.5% eye drops into the conjunctival sac, 1 drop 4 times daily, compared to the use of PVP** alone [105].

• Femtosecond laser-assisted phacoemulsification (A16.26.093.001) for replacing a clouded crystalline lens is recommended in complicated situations (low corneal endothelial cell density, weakness or local failure of the lens zonular apparatus) to reduce the risk of complications [20, 23, 176-181].

LeRR CLoE 4Level of recommendation confidence C (level of evidence – 4)

Comments: Femtosecond laser-assisted phacoemulsification is an alternative to the extracapsular cataract surgery method [20]. The femtosecond laser is used to perform corneal incisions (main incision, paracenteses), anterior capsulotomy, and pre-fragmentation of the lens nucleus [22]. Currently, there is evidence supporting the appropriateness of femtosecond assistance in complicated cases [20-22].

• IOL implantation (A16.26.094) (including posterior chamber pseudophakic intraocular lens***, iris-fixated intraocular lens***, extended depth of focus pseudophakic posterior chamber intraocular lens***, anterior chamber pseudophakic intraocular lens***, iridocapsular fixation intraocular lens***) is recommended as a method for correcting aphakia in the absence of contraindications for all patients [6, 28, 188-190].

LeRR CLoE 4Level of recommendation confidence C (level of evidence – 4)

Comments: in case of a complicated surgical course, insufficient visual control, need for additional surgical treatment, or absence of the IOL model required for reliable intraocular fixation, it is recommended to complete the surgery without IOL implantation.

Comments: IOL fixation outside the capsular bag may be required in case of zonular pathology, compromise of the anterior and/or posterior lens capsules during surgery. An alternative choice may be IOL implantation in the posterior chamber with haptic fixation in the ciliary sulcus [28-35]. Suture fixation of a posterior chamber IOL to the iris or transsclerally is necessary in the absence of adequate capsular support [28-35]. If reliable intraocular IOL fixation is impossible, completing the surgery without IOL implantation is recommended.

• For aphakia correction in grade 3–4 lens subluxation, implantation of a pupillary IOL or three-piece IOL (Intraocular lens implantation A16.26.094) (including posterior chamber pseudophakic intraocular lens***, iris-fixated intraocular lens***, extended depth of focus pseudophakic posterior chamber intraocular lens***, anterior chamber pseudophakic intraocular lens***, iridocapsular fixation intraocular lens***) with iris suturing or scleral fixation, with possible three-port vitrectomy, is recommended [28-35].

LeRR CLoE 4Level of recommendation confidence C (level of evidence – 4)

• For mechanical pupil expansion during cataract surgery with a small pupil, the use of a disposable sterile polymeric iridocapsular retractor or a disposable sterile polymeric quadrilateral iris retractor is recommended [1, 35].

GDR CLE 5Grade of recommendation C (level of evidence – 5)

Cataract and Glaucoma Coexistence

• To reduce postoperative complications in adult patients, cataract surgery with IOL implantation (without concomitant glaucoma surgery) is recommended when primary angle-closure glaucoma is in initial or advanced stages, with intraocular pressure controlled by antiglaucoma medication instillations (antiglaucoma preparations and miotics S01E) [36, 37].

GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)

Comments: cataract surgery with IOL implantation may contribute to a moderate decrease in IOP postoperatively [36, 37].

• To prevent reactive hypertension after phacoemulsification with intraocular lens implantation in adult patients with POAG, hypotensive therapy in the pre- and postoperative period is recommended [103-104, 193].

GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)

• To compensate for IOP and replace the opacified crystalline lens, combined simultaneous cataract and glaucoma surgery is recommended (A16.26.093.002 Phacoemulsification with intraocular lens implantation combined with antiglaucoma surgery, including A16.26.117 Non-penetrating deep sclerectomy, A16.26.117.001 Non-penetrating deep sclerectomy with drainage, A16.26.118 Other non-penetrating antiglaucoma procedures, A16.26.133 Micro-invasive Schlemm's canal surgery, A16.26.070 Trabeculectomy (sinustrabeculectomy)) in the absence of IOP compensation on maximum hypotensive therapy [36-40, 194, 195].

GCR BLEL 3Grade of Recommendation B (Level of Evidence – 3)

Comments: Phacoemulsification combined with antiglaucoma surgery can promote both IOP normalization and improvement of the best corrected visual acuity [36-40]. The advantages of combined surgery include the prevention of a sharp reactive IOP spike in the early postoperative period and a sustained hypotensive effect achieved through a single intervention [36-40].

• To reduce the negative impact of high IOP intraoperatively (during phacoemulsification with intraocular lens implantation), adult patients are recommended to use its optimal safe values, set and controlled by equipment (using ophthalmic surgical systems). IOP close to physiological levels can be considered the target. The surgeon should independently evaluate the feasibility and safety of intraoperative application of such pressure, including based on technical specifications of the systems used [94-96].

GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)

Pain Management

• At the current stage, surgical removal of the dislocated lens (A16.26.092.002) is recommended using the following methods: lensvitrectomy, phacoemulsification of the dislocated lens after its fixation and centration, and lens removal through a corneoscleral incision after delivering it into the anterior chamber of the eye [138, 212].

GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)

Optics and Refraction

• For the correction of aphakia and reduction of spherical aberrations, patients are recommended to receive monofocal spherical and aspheric IOLs (including posterior chamber pseudophakic intraocular lens***, iris-fixated intraocular lens***, extended depth of focus posterior chamber pseudophakic intraocular lens***, anterior chamber pseudophakic intraocular lens***, and iridocapsular-fixated intraocular lens***) [41-48, 196, 197].

GRC BLEL 2Grade of Recommendation B (Level of Evidence – 2)

Comments: spherical IOLs are characterized by the presence of positive spherical aberrations due to the fact that rays passing through the edges of the lens are focused proximally relative to paraxial rays. The design of aspheric IOLs makes it possible to reduce or eliminate spherical aberrations of the eye. Clinical study results demonstrate a pupil size-dependent reduction in spherical aberrations of the eye with aspheric IOL implantation. A number of studies demonstrate an improvement in contrast sensitivity indices when using aspheric IOLs compared to spherical ones [41-48].

• Toric intraocular lenses (including posterior chamber pseudophakic intraocular lens ***) for the correction of aphakia are recommended for patients with corneal astigmatism from 1.25 D, provided that in-the-bag IOL fixation is achieved [49-53, 198, 199].

LeR CLoE 4Level of Evidence/Recommendation Grade C (Level of Evidence – 4) – adults

LeR BLoE 2Level of Evidence/Recommendation Grade B (Level of Evidence – 2) – children

Comments: keratometry of patients with cataract showed that astigmatism of more than 1.25 D is present in 25.9% of cases [54]. It was also revealed that toric IOLs reduce spectacle dependence compared to standard spherical or aspheric monofocal IOLs [49-53]. Multifocal toric IOLs are indicated for corneal astigmatism starting from 1.0 D.

• Patients without concomitant ocular pathology (AMD, glaucoma, diabetes mellitus, corneal pathology, amblyopia, etc.) who express a desire not to use spectacle correction for reading and close-up work are recommended to consider the implantation of multifocal IOLs or extended depth of focus IOLs [55-57, 87-88].

GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)

Comments: the multifocality effect of IOL optics is achieved by splitting light rays into two or more focuses. Meta-analysis of literature data shows the superiority of multifocal IOLs over monofocal ones in providing near vision without additional spectacle correction while maintaining identical distance visual acuity indices. However, the use of multifocal IOLs is more frequently accompanied by optical phenomena in the form of glares, increased glare sensitivity, and the formation of halos around a light source (halo effect) [55-57]. High uncorrected near visual acuity is an important motivating factor in favor of choosing multifocal IOLs in the absence of occupational (drivers, workers engaged in visually demanding labor) or medical (concomitant ocular pathology) contraindications. Proper patient selection and detailed patient information are particularly important when using multifocal IOLs.

• To calculate IOL optical power (including toric, multifocal, multifocal toric, and extended depth of focus lenses) in all patients with complicated cataract, during preoperative and intraoperative eye status evaluation, the use of diagnostic and analytical (including navigation) systems incorporating new-generation calculation formulas is recommended [89-93].

GRC BLEL 2Grade of Recommendation B (Level of Evidence – 2)

Comments: the use of new-generation IOL calculation formulas in combination with modern high-tech diagnostic, analytical, and navigation systems and/or software allows for the comparison of preoperative planning data and real-time intraoperative digital control during IOL positioning, which contributes to achieving target refractive outcomes.

Posterior capsule opacification

Comments: The time frame for the development of secondary cataract from the moment of cataract extraction varies [69-73]. The frequency of Nd:YAG laser capsulotomy also varies, ranging from 3 to 53% within 3 years [73]. According to the Cataract PORT (Cataract Patient Outcomes Research Team) study, the incidence of secondary cataract within the first 4 months after surgery was 19.2%. Newer, well-designed case-series studies have shown that within 3-5 years, when using silicone or hydrophobic acrylic IOLs with sharp optic edges, posterior capsulotomy was required in 0-4.7% of cases [69-73]. Nd:YAG laser capsulotomy is an effective surgical method for eliminating posterior capsule opacification, promoting the restoration of visual functions and improving contrast sensitivity. The indication for this procedure is the presence of posterior capsule opacification that causes a decrease in visual acuity to a level that does not satisfy the patient's functional needs or impairs fundus visualization.

Dietary therapy is not used.

3.3. Other treatment

Not applicable

4. Medical Rehabilitation and Sanatorium-Resort Treatment

• If there are contraindications to surgical treatment (IOL implantation) in aphakic patients, it is recommended to prescribe optical correction aids (spectacle correction A23.26.001, contact lens correction A23.26.002) [213].

GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)

5. Prevention and Dispensary Observation

Comments: a follow-up ophthalmologist's appointment (examination, consultation) is indicated more frequently in case of an atypical postoperative course and the development of complications. In order to determine patients' subjective satisfaction with the results of the treatment, various assessment tools can be used, in particular the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) (Appendix G1-GN) [79, 80].

• At each follow-up ophthalmologist's appointment (examination, consultation) to assess the condition of the eye, it is recommended to perform a certain scope of procedures:

- taking an interval history (medications used, presence of new symptoms, and the patient's assessment of their vision);

- determination of visual functions (visometry, including testing with a pinhole occluder, and refractometry (if indicated);

- ophthalmodynamometry / ophthalmotonometry;

- biomicroscopy of the eye;

- counseling and training of the patient or accompanying person;

- determining further management tactics [6, 7, 204, 205].

GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)

Comments: ophthalmoscopy under conditions of drug-induced mydriasis is indicated if there are well-founded suspicions or a high risk of fundus pathology. In cases where there is insufficient improvement in visual functions compared to expected, additional diagnostic measures are necessary to determine the cause.

Comments: the possibilities of preventing the development of cataracts, as well as its medical treatment, are unproven. Most studies have not revealed a reliable reversal of the cataractogenesis process as a result of oral vitamin (A11) and mineral supplementation. The results of some studies indicate a relationship between smoking and nuclear sclerosis of the lens and point to a dose-dependent effect. The cumulative impact of ultraviolet rays over long periods of an individual's life may also be associated with lens opacification.

• All patients are recommended to quit smoking and achieve glycemic control in diabetes mellitus to prevent cataract development [84].

GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)

• All patients are recommended to avoid long-term systemic corticosteroid therapy to prevent cataract development [83, 207].

GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)

Comments: Patients receiving long-term oral corticosteroids (systemic corticosteroids H02) and inhaled corticosteroids (other agents for inhaled use for obstructive airway diseases – glucocorticoids R03BA) should be informed of the increased risk of cataract development and may wish to discuss alternative treatments with their primary care physician.

6. Organization of Medical Care

1) Outpatient ophthalmologist: initial ophthalmological examination (consultation), disease identification, diagnosis, referral to an inpatient, day care, or outpatient surgery setting for specialized (including high-tech) medical care.

2) In the medical organization: initial ophthalmological examination (consultation), follow-up ophthalmological examination (consultation), history taking, diagnostics, IOL power calculation, medical documentation processing, hospital admission or outpatient treatment provided adequate visual function of the fellow eye and patient mobility, subject to surgical indications.

3) Surgical intervention in outpatient or inpatient settings, postoperative diagnostics, examination by the attending physician.

4) The priority is the implementation of day-care forms of specialized medical care for patients with complicated cataracts, which allows for a greater volume of surgical treatment and more rational use of the material and technical resources of the medical institution and healthcare financial funds [119, 120].

The criterion for selecting patients for outpatient cataract phacoemulsification is the presence of cataracts without severe concomitant eye pathologies, such as extensive corneal opacity, grade 3-4 lens subluxation, or a small pupil with a diameter of less than 4 mm (under maximum pharmacological mydriasis). Patients must be sufficiently mobile, independently ambulatory, and able to attend postoperative follow-up visits [118, 119].

Postoperative examination is mandatory on the next day. Visometry A02.26.004 is performed (which consists of checking uncorrected and corrected visual acuity), along with ophthalmic tonometry and ocular biomicroscopy. In the postoperative period, to prevent the development of endothelial cell loss (EDPL) and non-specific inflammation, instillations of antimicrobial drugs S01A, corticosteroids S01BA, and/or non-steroidal anti-inflammatory drugs S01BC are used.

5) Discharge for outpatient rehabilitation if the patient's condition is satisfactory and inpatient stay is no longer required: follow-up examinations scheduled, discharge summary and recommendations provided, and sick leave certificate issued.

7. Additional Information

Criteria for Evaluating the Quality of Medical Care

References

Appendix A1. Working Group Composition

1. Gulzhiyana Sh. Arzhimatova – PhD in Medical Sciences, Head of the Moscow City Ophthalmological Center, Chief freelance ophthalmologist of the Moscow Healthcare Department, member of the "Ophthalmologists of Russia Society" LLC;

2. Sergey Yu. Astakhov – MD, Professor, Head of the Department of Ophthalmology, Pavlov First Saint Petersburg State Medical University of the Ministry of Health of the Russian Federation, Vice-President of the "Association of Ophthalmologists" LLC;

3. Mukharram M. Bikbov – MD, Professor, Director of the Ufa Eye Research Institute of the Academy of Sciences of the Republic of Bashkortostan, member of the Presidium of the "Association of Ophthalmologists" LLC, First Deputy Chairman of the Presidium of the "Ophthalmologists of Russia Society" LLC;

4. Olga V. Zaitseva – PhD in Medical Sciences, Deputy Director for Organizational and Methodological Work, National Medical Research Center of Eye Diseases named after Academician V.N. Helmholtz of the Ministry of Health of the Russian Federation, Leading Researcher at the Department of Retina Pathology, Executive Director of the "Association of Ophthalmologists" LLC;

5. Andrey V. Zolotarev – MD, Professor, Chief Physician of the Samara Regional Clinical Ophthalmological Hospital named after T.I. Eroshevsky, Head of the Department of Ophthalmology, Samara State Medical University, member of the Presidium of the "Association of Ophthalmologists" LLC;

6. Sergey Yu. Kopaev – MD, Head of the Department of Crystalline Lens Surgery and Intraocular Correction, S. Fyodorov Eye Microsurgery Federal State Institution of the Ministry of Health of the Russian Federation, member of the "Ophthalmologists of Russia Society" LLC;

7. Olga I. Orenburkina – MD, Director of the All-Russian Center for Eye and Plastic Surgery of the Bashkir State Medical University of the Russian Ministry of Health;

8. Kirill B. Pershin – MD, Professor, Academician of the Russian Academy of Natural Sciences, Medical Director of the "Excimer" Clinic Network, member of the "Ophthalmologists of Russia Society" LLC;

9. Nikolay P. Sobolev – PhD in Medical Sciences, Chief Physician of the S. Fyodorov Eye Microsurgery Federal State Institution of the Ministry of Health of the Russian Federation, member of the "Ophthalmologists of Russia Society" LLC;

10. Yury V. Takhtaev – MD, Professor of the Department of Ophthalmology, Pavlov First Saint Petersburg State Medical University, member of the "Ophthalmologists of Russia Society" LLC;

11. Nikolay E. Temirov – MD, Professor, Chief Physician of the "Lege Artis" Eye Clinic, Honored Doctor of the Russian Federation, member of the Board of the "Ophthalmologists of Russia Society" LLC;

12. Konstantin P. Telegin – Head of the Ophthalmological Department of City Hospital No. 40, Saint Petersburg, member of the "Ophthalmologists of Russia Society" LLC;

13. Vladimir N. Trubilin – MD, Professor, Head of the Ophthalmology Center of the FMBA of Russia, Head of the Department of Ophthalmology, Academy of Postgraduate Education of the Federal Medical-Biological Agency, member of the Presidium of the "Ophthalmologists of Russia Society" LLC, member of the Presidium of the "Association of Ophthalmologists" LLC;

14. Rinat R. Faizrakhmanov – MD, Professor, Head of the Ophthalmology Center of the Pirogov National Medical and Surgical Center of the Ministry of Health of the Russian Federation, member of the Presidium of the "Ophthalmologists of Russia Society" LLC;

15. Narzulla S. Khodjaev – MD, Professor, Honored Doctor of the Russian Federation, Deputy General Director for Research, S. Fyodorov Eye Microsurgery Federal State Institution of the Ministry of Health of the Russian Federation;

16. Naim Yu. Yusef – MD, Professor, Director of the M.M. Krasnov Research Institute of Eye Diseases, Honorary Professor of the Russian Medical Academy of Continuous Professional Education.

No conflict of interest.

Appendix A2. Methodology for Developing Clinical Guidelines

The methodology for developing clinical guidelines is based on evidence-based medicine methods. In these clinical guidelines, all information is ranked by the level of certainty of evidence depending on the quantity and quality of studies on the given issue.

Target audience for these clinical guidelines:

1. Ophthalmologists

2. Residents and postgraduate students in the specialty "Ophthalmology"

3. Students of higher medical educational institutions

Table 1. Scale for assessing levels of evidence (LE) for diagnostic methods (diagnostic interventions)

Table 2. Scale for assessing the levels of certainty of evidence (LCE) for methods of prevention, treatment, and medical rehabilitation, including those based on the use of natural therapeutic factors (preventive, therapeutic, and rehabilitation interventions)

Table 3. Scale for assessing the grades of recommendation (GR) for prevention, diagnostic, treatment, and medical rehabilitation methods, including those based on natural therapeutic factors (preventive, diagnostic, therapeutic, and rehabilitation interventions)

Procedure for updating clinical guidelines

The mechanism for updating clinical guidelines provides for their systematic revision – at least once every three years or upon the emergence of new evidence-based data regarding the diagnosis, treatment, prevention, and rehabilitation of specific diseases, the availability of justified additions or comments to previously approved clinical guidelines, but no more frequently than once every 6 months. The decision to update is made by the Russian Ministry of Health based on proposals submitted by medical non-profit professional organizations. The formulated proposals must take into account the results of a comprehensive assessment of the use of medicinal products, medical devices, and the results of clinical approbation.

Appendix A3. Reference Materials

Current instructions for medicinal products mentioned in these clinical guidelines can be found on the website http://grls.rosminzdrav.ru. Order of the Ministry of Health of the Russian Federation dated February 9, 2016, No. 80n (as amended on March 17, 2025) "On approval of the procedure for maintaining the state register of medicinal products for medical use".

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

1. Order of the Ministry of Health of the Russian Federation dated November 12, 2012, No. 902n "On approval of the Procedure for providing medical care to the adult population for diseases of the eye, its adnexa, and orbit".

2. Order of the Ministry of Health of the Russian Federation dated October 25, 2012, No. 422n "On approval of the Procedure for providing medical care to children for diseases of the eye, its adnexa, and orbit".

3. Order of the Government of the Russian Federation dated October 12, 2019, No. 2406-r (as amended on January 15, 2025) "On approval of the list of vital and essential drugs, as well as lists of medicinal products for medical use and the minimum assortment of medicinal products required for the provision of medical care".

Appendix B. Physician Action Algorithms

Complicated cataract

Combination of cataract and glaucoma

Acetazolamide ** - contraindicated in children under 3 years of age.

Appendix C. Patient Information

Patients with lens opacification seek primary care for initial complaints of gradual blurring of vision at a primary healthcare facility independently or are identified during annual health screenings. After the diagnosis of cataract with high visual acuity is established, the patient is scheduled for follow-up observation every 6 months. If visual functions decrease below 0.5 with correction and/or lead to a limitation in working capacity that no longer meets their needs and creates discomfort in daily life, the patient has the right to receive a referral for surgical treatment.

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

Appendix G1. National Eye Institute Visual Function Questionnaire

Russian title: National Eye Institute Visual Function Questionnaire.

Original title (if applicable): The National Eye Institute Visual Function Questionnaire (NEI-VFQ 25).

Source (official developer website, validation publication): [85, 86].

Type (underline):

• rating scale

• index

  questionnaire

• other (specify):

Purpose: patient's subjective assessment of visual functions.

Assessment tool, content:

Russian version of the NEI-VFQ 25 questionnaire [84, 85]

1. In general, would you say your health is:

   excellent ...................................1

   very good ............................. 2

   good ........................................ 3

   fair .................................... 4

   poor ............................................ 5

2. At present, would you say your vision in both eyes (using glasses or contact lenses, if you use them) is excellent, good, fair, poor, very poor?

   excellent .................................... 1

   good ..........................................2

   fair ......................................3

   poor ..............................................4

   very poor ................................... 5

   completely blind ........................... 6

3. How often do you worry about your eyesight?

   never .......................................................1

   rarely...........................................................2

   sometimes..........................................................3

   often........................................................... 4

   constantly.................................................... 5

4. How severe is the pain or discomfort you experience in or around your eyes (e.g., burning, itching, or aching)?

   do not occur................................ 1

   minor.......................................... 2

   moderate....................................3

   severe....................................... 4

   very severe.............................. 5

5. How difficult is it for you to read ordinary newspaper print?

   not difficult at all.........................................................................1

   a little difficult.......................................................................... 2

   quite difficult.........................................................................3

   extremely difficult...................................................................4

   stopped doing this because of vision.......................................... 5

   stopped doing this for other reasons

   or have no interest in it............................................... 6

6. How difficult is it for you to perform activities or hobbies that require:

   good near vision: cooking, sewing, minor home repairs, or using hand tools?

   not difficult at all............................................................................ 1

   a little difficult............................................................................... 2

   quite difficult............................................................................. 3

   extremely difficult....................................................................... 4

   stopped doing this because of vision............................................... 5

   stopped doing this for other reasons

   or have no interest in it.................................................... 6

7. Because of your vision, how difficult is it for you to find something on a shelf cluttered with various items?

   not difficult at all................................................................

   a little difficult............................................................................. 2

   quite difficult........................................................................... 3

   extremely difficult..................................................................... 4

   stopped doing this because of vision............................................. 5

   stopped doing this for other reasons

   or have no interest in it.................................................. 6

8. How difficult is it for you to read street signs, street names, or store names?

   not difficult at all............................................................................. 1

   a little difficult................................................................................ 2

   quite difficult.............................................................................. 3

   extremely difficult........................................................................ 4

   stopped doing this because of vision................................................ 5

   stopped doing this for other reasons

   or have no interest in it..................................................... 6

9. Because of your vision, how difficult is it for you to step down stairs, steps, or curbs in dim lighting or at night?

   not difficult at all...........................................................................1

   a little difficult.............................................................................. 2

   quite difficult............................................................................ 3

   extremely difficult...................................................................... 4

   stopped doing this because of vision.............................................. 5

   stopped doing this for other reasons

   or have no interest in it................................................... 6

10. Because of your vision, how difficult is it for you to notice objects to the sides while walking?

    not difficult at all........................................................................... 1

    a little difficult.............................................................................. 2

    quite difficult.............................................................................3

    extremely difficult...................................................................... 4

    stopped doing this because of vision...............................................5

    stopped doing this for other reasons

    or have no interest in it................................................... 6

11. Because of your vision, how difficult is it for you to see how people react to what you say to them?

    not difficult at all................................................................

    a little difficult............................................................................. 2

    quite difficult........................................................................... 3

    extremely difficult..................................................................... 4

    stopped doing this because of vision............................................. 5

    stopped doing this for other reasons

    or have no interest in it.................................................. 6

12. Because of your vision, how difficult is it for you to choose your clothes and match clothing items that go together?

    not difficult at all..........................................................................1

    a little difficult............................................................................. 2

    quite difficult........................................................................... 3

    extremely difficult..................................................................... 4

    stopped doing this because of vision............................................. 5

    stopped doing this for other reasons

    or have no interest in it................................................. 6

13. Because of your vision, how difficult is it for you to interact with people when visiting others?

    not difficult at all................................................................

    a little difficult............................................................................. 2

    quite difficult........................................................................... 3

    extremely difficult..................................................................... 4

    stopped doing this because of vision............................................. 5

    stopped doing this for other reasons

    or have no interest in it................................................. .6

14. Because of your vision, how difficult is it for you to go to the movies, theater, or sporting events?

    not difficult at all................................................................

    a little difficult.............................................................................. 2

    quite difficult........................................................................... 3

    extremely difficult..................................................................... 4

    stopped doing this because of vision............................................. 5

    stopped doing this for other reasons

    or have no interest in it.................................................. 6

15. If you currently drive: how difficult is it for you to drive during the day when driving in familiar places?

    not difficult at all....................................1

    a little difficult....................................... 2

    quite difficult..................................... 3

    extremely difficult............................... 4

16. How difficult is it for you to drive at night in familiar places?

    not difficult at all................................................................

    a little difficult............................................................................ 2

    quite difficult.......................................................................... 3

    extremely difficult.................................................................... 4

    stopped doing this because of vision............................................ 5

    stopped doing this for other reasons

    or have no interest in it................................................. 6

    16a. How difficult is it for you to drive in difficult conditions, such as bad weather, rush hour, highways, or city traffic?

    not difficult at all................................................................

    a little difficult............................................................................ 2

    quite difficult.......................................................................... 3

    extremely difficult.................................................................... 4

    stopped doing this because of vision.............................................5

    stopped doing this for other reasons

    or have no interest in it................................................. 6

17. Because of your vision, do you accomplish less than you would like?

    Constantly....................... 1

    Often............................... 2

    Sometimes............................. 3

    Rarely............................... 4

    Never............................ 5

18. Because of your vision, are you limited in how long you can work or perform other activities?

    Constantly..................... 1

    Often............................. 2

    Sometimes........................... 3

    Rarely............................. 4

    Never.......................... 5

19. How often do you have to give up things you would like to do because of pain or discomfort in or around your eyes, such as burning, itching, or aching?

    Constantly..................... 1

    Often............................. 2

    Sometimes........................... 3

    Rarely............................. 4

    Never.......................... 5

20. Because of my vision, I spend most of my time at home:

    completely true.........................................1

    mostly true...........................................2

    don't know........................................................... 3

    mostly false........................................4

    completely false...................................... 5

21. Due to my vision problems, I often feel irritated and dissatisfied:

    completely true...........................................1

    mostly true........................................... 2

    don't know............................................................ 3

    mostly false........................................ 4

    completely false........................................ 5

22. Due to my vision problems, I have significantly less control over what I do:

    completely true...........................................1

    mostly true............................................ 2

    don't know..............................................................3

    mostly false..........................................4

    completely false....................................... .5

23. Because of my vision, I have to rely too much on what others tell me:

    completely true........................................... 1

    mostly true............................................. 2

    don't know..............................................................3

    mostly false......................................... 4

    completely false........................................ 5

24. Due to vision problems, I often need help from others:

    completely true.........................................1

    mostly true.......................................... 2

    don't know........................................................... 3

    mostly false.......................................4

    completely false......................................5

25. I worry that because of my vision problems, I might do something that would make me or others feel awkward:

    completely true............................................1

    mostly true............................................. 2

    don't know.............................................................. 3

    mostly false.......................................... 4

    completely false......................................... 5

Interpretation

All questions in the questionnaire are grouped into blocks assessing the patient's physical, mental, and social functioning in relation to their visual quality of life. The total score across all sections of the method allows for assessing the degree of reduction in the patient's quality of life relative to their visual functions.