Senile cataract: Clinical guidelines

List of Abbreviations

AGS — antiglaucoma surgery

ATP synthase — adenosine triphosphate synthase IOP — intraocular pressure

AMD — age-related macular degeneration

GCS — glucocorticosteroids

YAG — yttrium-aluminum-garnet (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 Classification of Diseases 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 extracapsular fixation

RF — Russian Federation

TASS — toxic anterior segment syndrome (TASS syndrome)

UV rays — ultraviolet rays

Femto-CE — femtosecond-assisted cataract extraction

phaco — phacoemulsification

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 (phaco) is a surgical method for treating cataracts, which consists of ultrasonic fragmentation of the lens nucleus inside the capsular bag, followed by its aspiration and subsequent implantation of an intraocular lens (IOL).

Femtosecond-assisted phacoemulsification (Femto-phaco) is a two-stage procedure: in the first stage, a femtosecond laser is used to make corneal incisions, perform capsulotomy, and fragment the nucleus; in the second stage, lens matter is evacuated using vacuum, followed by 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

Age-related cataract is a pathological condition associated with partial or complete opacification of the eye lens, which typically develops in people after the age of 60 and manifests with varying degrees of visual impairment up to complete loss of form vision.

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

Risk factors

Numerous risk factors associated with cataract development are presented in Table 1. The most common among them are age, diabetes mellitus, prolonged use of topical, systemic, or inhaled glucocorticosteroids, and previous intraocular surgery.

Table 1. Factors associated with an increased risk of cataract development

Most studies on risk factors for cataract development are observational, suggest the presence of associations, but cannot reliably prove cause-and-effect relationships, as they do not investigate cataract progression or exposure to risk factors in a standardized manner.

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

1.3 Epidemiology of the Disease or Condition

Cataracts are one of the main causes of low vision and reversible blindness in the world, affecting every sixth person over the age of 40 and the vast majority of the population by the 8th decade of life. Given the gradually increasing life expectancy, particularly characteristic of economically developed countries, the number of cataract patients is projected to increase from the current 20 million to 40 million people by 2020. According to published data, the overall prevalence of cataract in the Russian Federation (RF) is 3.36% for the urban population and 3.63% for the rural population. In the only current population-based study in the Russian Federation on the prevalence of visual impairment from cataracts, performed according to the international RAAB (Rapid Assessment of Avoidable Blindness) standard and based on cluster sampling of a randomized cohort (4,044 people per 336,000 population aged over 50 years), visual reduction from cataracts to 0.3 and below occurred in 8.69% of those examined. At the same time, cataracts were 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].

1.4 Features of Coding the Disease or Condition

H25.0 — Senile incipient cataract

H25.1 — Senile nuclear cataract

H25.2 — Senile cataract, morgagnian type

H25.8 — Other senile cataracts

H25.9 — Senile cataract, unspecified

1.5 Classification of the disease or condition

5.1. 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.

5.2. By the degree of maturity [4]:

1. incipient cataract;

2. immature cataract;

3. mature cataract;

4. hypermature cataract.

1.6 Clinical presentation of the disease or condition

During a slit-lamp examination with a wide pupil, incipient cataract reveals subcapsular vacuoles and splitting of lens fibers. Immature cataract is characterized by a white-gray, yellow, or brown nucleus, and cortical opacities in the form of spokes may also be present. Mature cataract presents with total opacification of the lens, with a white nucleus and cortical masses. In hypermature cataract, the cortical substance turns into a liquefied milky-white mass that gradually resorbs, and the dense nucleus sinks downwards.

2. Diagnostics, medical indications and contraindications for diagnostic methods

2.1 Complaints and Anamnesis

• When examining a patient with senile cataract, a thorough history taking and assessment of complaints are recommended to evaluate the timing and rate of vision loss, as well as general health status [5, 6].

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

Comments: blurred vision followed by its gradual decline are characteristic symptoms of lens opacification, although similar complaints may also occur in 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 decline in visual functions and cataract progression. Anamnestic data collection includes assessing the timing and rate of visual function impairment, the patient's subjective description of their visual and functional capabilities, general health status, medications taken, and other risk factors that may affect the course and outcome of surgery (immunodeficiency states, systemic use of alpha-1 adrenergic receptor antagonists, diabetes mellitus, allergies, etc.).

During the initial examination of a patient with cataract, it is necessary to:

• 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 optimal treatment tactics;

• evaluate the prognosis of visual function recovery in the postoperative period.

2.2 Physical Examination

Comments: the optical correction power must be recorded in the medical documentation; near vision testing is performed when indicated.

2.3 Laboratory Diagnostics

Specific laboratory diagnostics for age-related 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.

Comments: the main technique 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 has a higher margin of error and becomes necessary 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 Placido disc principle), keratotomography (based on Scheimpflug photography of the anterior segment of the eyeball), or optical coherence tomography of the cornea is used

2.5 Other Procedures

In most patients, the ophthalmologist can determine the contribution of the cataract to the decline in visual functions by comparing biomicroscopy results with the patient's specific symptoms.

Sometimes the patient's visual symptoms are disproportionate to the severity of the cataract. Determining visual acuity alone does not allow for a quantitative assessment of a number of visual symptoms, such as, in particular, reduced resistance to glare and loss of contrast sensitivity. Examinations in a dark room with high contrast and a brightly lit object can significantly underestimate the functional problems experienced by a patient under conditions of varying illumination and contrast.

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 counterbalanced by the natural positive spherical aberrations of the cornea. In cataracts, the lens aberrations turn positive, and the established balance is disrupted, leading to a decrease in 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.

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

Conservative treatment

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

Surgical treatment

Comments: among the variety of surgical operations, ultrasound phacoemulsification (PE) has become the most widespread at the present stage.

Comments: it should be stated that there are no universal and generally accepted research methods that allow linking the state of visual functions with the patient's quality of life, impairment of their working capacity, and ability to perform routine household activities.

Comments: in modern conditions, when patients make high demands on the quality of life and do not accept the need for functional limitations associated with decreased vision, there are grounded prerequisites for expanding indications and earlier cataract surgery. The current stage of development of surgical technologies justifies the feasibility of introducing into clinical practice a conditional threshold equal to the loss of central vision to the level of 0.5 with correction.

Indications for surgical treatment of cataract are:

• decreased visual acuity;

• clinically significant anisometropia associated with cataract; lens opacities that complicate the diagnosis and/or treatment of posterior segment diseases of the eye;

• ophthalmotonus disorders associated with the development of cataract (phacomorphic, phacolytic, phacoanaphylactic, phacotopic glaucomas);

Relative contraindications to surgical intervention for 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 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 when the surgeon does not expect an improvement in visual functions as a result of the operation and at the same time 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 the patient's preoperative examination (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 to replace an opacified lens or correct ametropia while maintaining the ligamentous apparatus of the lens and the capsular bag, extracapsular cataract extraction (ECCE) is recommended. The preferred and most widespread variant of ECCE is phacoemulsification (PE) [18]. To prevent infectious complications, the use of antibacterial drugs and/or antimicrobial drugs before surgical intervention is possible (in the absence of medical contraindications). All patients need therapy with medicinal products: anticholinergic agents and/or sympathomimetic groups (excluding antiglaucoma drugs) for 1 hour before surgical intervention (in the absence of medical contraindications).

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

Comments: Literature data favor the use of povidone-iodine** (PVI) as the main proven preoperative intervention to reduce the incidence of postoperative endophthalmitis [25]

• Local application of povidone-iodine** (PVI) during cataract surgery is recommended for all patients. A mandatory step, the purpose of which is to reduce the number of bacteria in the wound area, consists in applying 5–10% povidone-iodine** to the cornea, conjunctival sac, and skin around the eye at least 3 minutes before the start of the operation. [25, 129] In cases where the use of povidone-iodine** is contraindicated (true allergy is rare, and hyperthyroidism is only a relative contraindication to this type of single application), a 0.05% aqueous solution of chlorhexidine** can be used [25]

Level of Evidence AGrade of Evidence 2Level of Recommendations A (Grade of Evidence – 2)

Comments: The results of a prospective randomized study showed the advantages of combined antibiotic prophylaxis using povidone-iodine** (PVI) in combination with 0.5% #levofloxacin** solution compared to the use of PVI alone [105]. According to another prospective randomized study, 1-day local administration of 0.5% #moxifloxacin solution, 1 drop in the affected eye 4 times a day.**, had the same efficacy in reducing the number of bacteria on the conjunctiva in the perioperative period compared to its 3-day local administration [106].

• For cataracts of dense consistency, the use of the laser cataract extraction method is recommended [19].

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

Comments: in a randomized study of ECCE and PE through a small surgical incision, the advantages of the latter were revealed in terms of fewer surgical operations and statistically significantly better visual acuity; a low incidence of secondary cataract development during the 1st year of observation was also established.

Comments: Femtosecond-assisted phacoemulsification – an alternative approach to extracapsular cataract surgery [20]. A femtosecond laser is used to perform corneal incisions (main, paracenteses), anterior capsulotomy, and pre-fragmentation of the lens nucleus [22]. To date, there are no randomized trials that convincingly substantiate the advantages

of femtosecond-assisted ECCE in age-related cataract surgery, however, there are data on the feasibility of using femtosecond assistance in complicated cases [20-22].

Comments: intracameral administration of an antibacterial drug solution immediately upon completion of cataract extraction makes it possible to significantly (5–7 times) reduce the likelihood of acute postoperative endophthalmitis [25]. In the postoperative period of uncomplicated cataract surgery, drug treatment is prescribed in the form of instillations of antibacterial drugs (up to 14 days), topical glucocorticosteroids (up to 30 days), and nonsteroidal anti-inflammatory drugs (up to 30 days post-op).

Comments: The results of a multicenter study conducted by the European Society of Cataract and Refractive Surgeons demonstrated a statistically significant decrease in the incidence of POE for cefuroxime** [111]. The literature describes the efficacy of intracameral administration of moxifloxacin** in separate series of observations [112, 113]. The results of a meta-analysis by Kessel, Line et al. [114] showed a significant reduction in the risks of POE with the intracameral use of cefazolin**, cefuroxime**, and moxifloxacin** solutions compared to placebo. The benefit of routine antibiotic prophylaxis of endophthalmitis with intracameral use of vancomycin** has not been proven.

• IOL implantation is recommended as a method of aphakia correction in the absence of contraindications for all patients [6, 28].

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

Comments: fixation of the IOL outside the capsular bag may be required in case of zonular weakness or compromise of the integrity of the anterior and/or posterior lens capsule during surgery. Options may include implantation of an anterior chamber IOL with fixation of the lens haptics in the anterior chamber angle or to the iris, as well as posterior chamber IOL implantation with ciliary sulcus fixation [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].

• For the correction of aphakia in grade 3-4 lens subluxation, it is recommended to implant a pupillary IOL or a three-piece IOL with iris suturing or scleral fixation [28-35].

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

• For mechanical pupil dilation, it is recommended to use a disposable sterile polymeric iris-capsular retractor or a disposable sterile polymeric quadrilateral iris retractor during cataract surgery with a small pupil [1, 35].

GCR CLoE 3Grade of Recommendation C (Level of Evidence – 3)

Cataract and glaucoma combination

• To reduce postoperative complications, it is recommended to perform cataract surgery with IOL implantation (without concomitant glaucoma surgery) in primary angle-closure glaucoma of early or moderate stages, provided the intraocular pressure (IOP) is compensated by hypotensive medications [36, 37].

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

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

• To prevent reactive hypertension after phacoemulsification in patients with primary open-angle glaucoma (POAG), it is recommended to use hypotensive therapy in the pre- and postoperative periods [103-104].

GCR CLEL 4Grade of Recommendation C (Level of Evidence - 4)

• To normalize IOP and replace the opaque lens, combined simultaneous cataract and glaucoma surgery is recommended if IOP is not compensated on a maximum hypotensive regimen [36-40].

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

Comments: Phacoemulsification combined with glaucoma surgery can contribute to both IOP normalization and improvement of the best corrected visual acuity [36-40]. The advantage of combined surgery includes 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 mitigate the negative impact of high intraoperative IOP (during phacoemulsification), it is recommended to use the most optimal and safe values set and controlled by the equipment (using ophthalmic surgical systems). The target IOP may be considered close to physiological levels. The surgeon must independently assess the feasibility and safety of intraoperative application of such pressure, including based on technical specifications of the systems used [94-96].

Level of Recommendation BLevel of Evidence 4Level of Recommendation B (Level of Evidence - 4)

Pain Management

Dietary therapy

Not applicable.

Optics and refraction

• For the correction of aphakia and reduction of spherical aberrations, it is recommended that patients receive monofocal aspheric IOLs [41-48].

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

Comments: spherical IOLs are characterized by positive spherical aberrations because rays passing through the edge of the lens are focused proximally relative to paraxial rays. The design of aspheric IOLs helps reduce or eliminate ocular spherical aberrations. Clinical studies show a pupil size-dependent reduction in ocular spherical aberrations with aspheric IOL implantation. Several studies demonstrate improved contrast sensitivity parameters when using aspheric IOLs compared to spherical ones [41-48].

• Toric IOLs for aphakia correction are recommended for patients with corneal astigmatism of 1.25 D or more [49-53].

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

Comments: keratometry in cataract patients has shown that 25.9% of cases have astigmatism greater than 1.25 D [54]. It has also been found 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.

• For patients without concomitant ocular pathology (AMD, glaucoma, diabetes mellitus, corneal pathology, amblyopia, etc.) who express a desire to be free from spectacle correction for reading and close work, it is recommended to consider the implantation of multifocal IOLs or extended depth of focus (EDOF) IOLs [55-57, 87-88].

GCR ALEL 1Grade of Recommendation A (Level of Evidence – 1)

Comments: the multifocality effect of IOL optics is achieved by splitting light rays into two or more foci. A meta-analysis of literature data demonstrates the superiority of multifocal IOLs over monofocal ones in providing near vision without additional spectacle correction while maintaining identical distance visual acuity. However, the use of multifocal IOLs is more frequently accompanied by optical phenomena such as glare, increased dazzle, and the formation of light rings 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, visually demanding work) or medical (concomitant eye pathology) contraindications. Proper patient selection and detailed counseling are particularly important when using multifocal IOLs.

• To calculate the optical power of IOLs (including toric, multifocal, multifocal toric, and EDOF IOLs), diagnostic and analytical (including navigation) systems incorporating next-generation calculation formulas are recommended for all patients with senile cataracts during pre- and intraoperative ocular assessment [89-93].

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

Comments: the use of new-generation IOL calculation formulas combined 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% over 3 years [73]. According to the Cataract PORT (Cataract Patient Outcomes Research Team) study, the incidence of secondary cataract development during the first 4 months after surgery was 19.2%. Newer, well-designed case series studies have shown that over 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]. An effective surgical method to eliminate posterior capsule opacification, promoting the restoration of visual functions and improvement of contrast sensitivity, is Nd:YAG laser capsulotomy. The indication for this procedure is the presence of posterior capsule opacification that causes a decrease in visual acuity to a level that fails to meet the patient's functional needs or impairs fundus visualization.

4. Medical Rehabilitation and Sanatorium-Resort Treatment

Level of Recommendation C (Level of Evidence

5. Prevention and Dispensary Observation

• In the absence of complications, the frequency and schedule of subsequent postoperative follow-up examinations depend on the dynamics of clinical recovery. Normally, this is on the 1st, 7th, and 30th days after surgery. More frequent examinations are recommended for all patients who experience an atypical postoperative course, as well as in the event of complications [6, 7, 75–78]. To determine patients' subjective satisfaction with the treatment outcomes, various assessment tools can be used [79, 80].

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

• At each postoperative follow-up, all patients are recommended to undergo a specific scope of procedures to assess the condition of the eye:

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

• determining visual functions (visual acuity testing, including testing with a pinhole and refractometry as clinically indicated);

• measurement of IOP;

• biomicroscopy of the eye;

• counseling and instruction of the patient or accompanying person;

• determining further management tactics [6, 7].

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

Comments: fundus examination under pharmacological mydriasis is indicated if there is reasonable suspicion or a high risk of fundus pathology. In cases where there is an insufficient improvement in visual functions compared to what was expected, additional diagnostic measures are necessary to identify the cause.

Comments: preventive options for cataract development, as well as its drug therapy, remain unproven. Most studies have not revealed a reliable reversal of the cataractogenesis process as a result of oral multivitamin and mineral supplements. The results of some studies indicate a correlation between smoking and lens nuclear sclerosis and suggest a dose-dependent effect. Cumulative exposure to ultraviolet radiation 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].

GCR BLoE 3Level of Evidence B (Level of Confidence of Evidence – 3)

Comments: patients on long-term oral and inhaled corticosteroids should be informed about the increased risk of cataract development and may wish to discuss alternative treatment methods with their primary care physician.

6. Organization of Medical Care

1. Outpatient clinic physician: primary examination, disease detection, diagnosis formulation, referral to an inpatient, day care, or outpatient surgery setting to provide specialized (including high-tech) medical care.

2. At the medical organization: examination by an ophthalmic surgeon, history taking, diagnostics, IOL power calculation, medical documentation preparation, hospitalization or outpatient surgery if the fellow eye has high visual functions and the patient is sufficiently mobile, provided surgical indications are met.

3. Performance of surgical intervention in outpatient or inpatient settings, postoperative diagnostics, examination by the attending physician.

4. The predominant approach is the implementation of replacement forms of specialized medical care for patients with senile cataracts, which allows for a greater volume of surgical treatment, more rational use of the material and technical resources of the medical institution, and healthcare financial resources [119, 120].

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

   Patients are required to attend a postoperative follow-up visit the next day. Uncorrected and corrected visual acuity is checked, and biomicroscopy is performed. In the postoperative period, patients are prescribed local antibacterial and anti-inflammatory therapy in the form of eye drops (latest-generation fluoroquinolones + glucocorticosteroids), and tear substitutes or non-steroidal anti-inflammatory therapy if necessary.

5. Discharge for outpatient follow-up in a satisfactory condition with no need for inpatient care: follow-up visits scheduled, discharge summary and recommendations provided, sick leave certificate issued.

7. Additional Information

• Cataract surgery after an acute cerebrovascular accident is recommended no earlier than 9–12 months to prevent general somatic complications and after obtaining clearance from a neurologist. At the same time, postoperative functional outcomes may be reduced due to damage to the central visual pathway [126, 127].

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

• In patients after pacemaker implantation, it is recommended to exclude all types of diathermy and radiofrequency coagulation, including Klotz radiofrequency capsulorhexis, to prevent cardiovascular complications. Opening of the anterior lens capsule should be performed manually using forceps technique. If capillary hemostasis is required, a non-contact Nd:YAG laser method, medical treatment, or thermal application with a metal instrument heated over an alcohol lamp flame can be used [126].

• Cataract surgery does not require a specific type of diet. Patients without severe comorbid somatic conditions are recommended Diet No. 15; in mild-to-moderate diabetes mellitus, Diet No. 9 is recommended. In other situations, as prescribed by a general practitioner [128].

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

Criteria for Evaluating the Quality of Medical Care

References

Appendix A1. Working Group Composition

1. Amirov Aidar Nailevich – Candidate of Medical Sciences, Head of the Department of Ophthalmology, Kazan State Medical Academy of the Ministry of Health of the Russian Federation, Member of the Presidium of the Association of Ophthalmologists, Member of the Presidium of the Society of Ophthalmologists of Russia;

2. Astakhov Sergey Yuryevich – Doctor of Medical Sciences, Professor, Head of the Department of Ophthalmology, Academician I.P. Pavlov First Saint Petersburg State Medical University of the Ministry of Health of the Russian Federation, Vice-President of the Association of Ophthalmologists;

3. Belikova Elena Ivanovna – Doctor of Medical Sciences, Professor of the Department of Ophthalmology, Academy of Postgraduate Education under the Federal Research and Clinical Centre of the Federal Medical-Biological Agency, Chief Physician of the "Dr. Belikova Eye Clinic", Member of the Society of Ophthalmologists of Russia;

4. Bikbov Mukharram Mukhtaramovich – Doctor of Medical Sciences, 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, First Deputy Chairman of the Presidium of the Society of Ophthalmologists of Russia;

5. Egorova Elena Vladilenovna – Candidate of Medical Sciences, Deputy Director for Medical Work, Novosibirsk Branch of the Academician S.N. Fyodorov Eye Microsurgery Federal State Institution of the Ministry of Health of the Russian Federation, Member of the Society of Ophthalmologists of Russia;

6. Kozhukhov Arseny Aleksandrovich – Doctor of Medical Sciences, Professor, Leading Ophthalmic Surgeon of the "SPEKTR" Eye Clinic, Moscow, Member of the Society of Ophthalmologists of Russia;

7. Konovalov Mikhail Egorovich – Doctor of Medical Sciences, Professor, Chief Physician of the "Konovalov Ophthalmological Center", Moscow, Member of the Presidium of the Society of Ophthalmologists of Russia;

8. Kopaev Sergey Yuryevich – Doctor of Medical Sciences, Head of the Department of Lens Surgery and Intraocular Correction, Academician S.N. Fyodorov Eye Microsurgery Federal State Institution of the Ministry of Health of the Russian Federation, Member of the Society of Ophthalmologists of Russia;

9. Kochmala Oleg Borisovich – Doctor of Medical Sciences, Chief Physician of the "Iris Eye Clinic", Rostov-on-Don, Member of the Society of Ophthalmologists of Russia;

10. Kulikov Aleksey Nikolaevich – Doctor of Medical Sciences, Head of the Department of Ophthalmology, S.M. Kirov Military Medical Academy, Chief Ophthalmologist of the Ministry of Defense of the Russian Federation, Member of the Presidium of the Society of Ophthalmologists of Russia;

11. Laptev Boris Vladimirovich – Head of the Operating Unit, "Ekaterinburg Center of Eye Microsurgery" CJSC, Member of the Society of Ophthalmologists of Russia;

12. Malyugin Boris Eduardovich – Doctor of Medical Sciences, Professor, Deputy Director General for Research, Academician S.N. Fyodorov Eye Microsurgery Federal State Institution of the Ministry of Health of the Russian Federation, Chairman of the Society of Ophthalmologists of Russia;

13. Mamikonyan Vardan Rafaelovich – Doctor of Medical Sciences, Professor, Deputy Director for Science, Research Institute of Eye Diseases of the Russian Academy of Medical Sciences, Member of the Board of the Society of Ophthalmologists of Russia;

14. Pershin Kirill Borisovich – Doctor of Medical Sciences, Professor, Academician of the Russian Academy of Natural Sciences, Medical Director of "Excimer" Eye Clinics, Member of the Society of Ophthalmologists of Russia;

15. Sobolev Nikolay Petrovich – Candidate of Medical Sciences, Chief Physician of the Academician S.N. Fyodorov Eye Microsurgery Federal State Institution of the Ministry of Health of the Russian Federation, Member of the Society of Ophthalmologists of Russia;

16. Takhtaev Yury Viktorovich – Doctor of Medical Sciences, Professor, Professor of the Department of Ophthalmology, Academician I.P. Pavlov First St. Petersburg State Medical University, Member of the Society of Ophthalmologists of Russia;

17. Trubilin Vladimir Nikolaevich – Doctor of Medical Sciences, Professor, Head of the Ophthalmology Center of the Federal Medical-Biological Agency of Russia, Head of the Department of Ophthalmology, Academy of Postgraduate Education of the Federal Research and Clinical Centre of the Federal Medical-Biological Agency, Member of the Presidium of the Society of Ophthalmologists of Russia, Member of the Presidium of the Association of Ophthalmologists;

18. Chentsova Ekaterina Valerianovna – Doctor of Medical Sciences, Professor, Acting Head of the Department of Traumatology, Reconstructive Surgery and Ocular Prosthetics, Helmholtz National Medical Research Center of Eye Diseases of the Ministry of Health of the Russian Federation, Member of the Association of Ophthalmologists.

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

Table 2. Scale for grading levels of evidence certainty (LEC) 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 clinical guideline update mechanism provides for their systematic revision—at least once every three years or upon the appearance of new information on the management tactics for patients with a given disease. 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 drugs and medical devices, as well as the results of clinical approbation.

Appendix A3. Reference Materials

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

1. Order of the Russian Ministry of Health No. 902n dated November 12, 2012, "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 Russian Ministry of Health No. 422n dated October 25, 2012, "On Approval of the Procedure for Providing Medical Care to Children for Diseases of the Eye, Its Adnexa, and Orbit".

List of systemic antibacterial drugs used for the treatment of acute bacterial postoperative endophthalmitis (ABPE)

Analysis of factors influencing the bioavailability of antimicrobial drugs into the aqueous humor of the anterior chamber upon systemic administration

Appendix B. Physician Action Algorithms

Senile cataract

Combination of cataract and glaucoma

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

Bp

Russian title: National Eye Institute Visual Function Questionnaire

Original title (if available): 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. Overall, would you say your health is:

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

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

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

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

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

2. At the present time, would you say your vision in both eyes (with glasses or contact lenses, if you use them) is excellent, good, fair, poor, or 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 much pain or discomfort do you experience in and around your eyes (e.g., burning, itching, or an aching pain)?

none...................... 1

mild................. 2

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

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

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

5. How difficult is it for you to read ordinary newspaper print? not at all difficult....................................................... 1

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

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

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

stopped doing this due to vision......................... 5

stopped doing this for other reasons or not interested........................... 6

6. How much difficulty do you have doing the work or other everyday activities you would like to do because of your vision?

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

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

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

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

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

stopped doing this because of eyesight....................... 5

stopped doing this for other reasons or not interested............................. 6

7. Because of your eyesight, how much difficulty do you have finding something on a shelf crowded with items?

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

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

moderately difficult...................................................... 3

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

stopped doing this because of eyesight....................... 5

stopped doing this for other reasons or not interested............................ 6

8. How much difficulty do you have reading street signs, traffic signs, or store names?

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

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

moderately difficult......................................................... 3

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

stopped doing this due to vision......................... 5

stopped doing this for other reasons or not interested............................... 6

9. Because of your eyesight, how much difficulty do you have stepping down steps, stairs, or curbs in dim light or at night?

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

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

moderately difficult...................................................... 3

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

stopped doing this because of eyesight...................... 5

stopped doing this for other reasons or not interested............................ 6

10. Because of your eyesight, how much difficulty do you have noticing objects off to the side while walking?

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

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

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

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

stopped doing this because of eyesight........................ 5

stopped doing this for other reasons or not interested.............................. 6

11. Because of your eyesight, how much difficulty do you have seeing how people react to things you say?

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

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

moderately difficult...................................................... 3

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

stopped doing this because of eyesight....................... 5

stopped doing this for other reasons or not interested............................. 6

12. Because of your eyesight, how much difficulty do you have picking out and matching your clothes?

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

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

moderately difficult...................................................... 3

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

stopped doing this because of eyesight....................... 5

stopped doing this for other reasons or not interested............................. 6

13. Because of your eyesight, how much difficulty do you have visiting with people in their homes?

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

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

moderately difficult...................................................... 3

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

stopped doing this because of eyesight....................... 5

stopped doing this for other reasons or not interested............................. 6

14. Because of your eyesight, how much difficulty do you have going to movies, plays, or sporting events?

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

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

moderately difficult...................................................... 3

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

stopped doing this because of eyesight....................... 5

stopped doing this for other reasons or not interested............................. 6

15. If you currently drive: how much difficulty do you have driving during the day in familiar places?

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

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

moderately difficult........................ 3

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

16. How much difficulty do you have driving at night in familiar places?

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

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

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

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

stopped doing this because of eyesight...................... 5

stopped doing this for other reasons or not interested............................ 6

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

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

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

quite a bit of difficulty..................................................... 3

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

stopped doing this because of eyesight....................... 5

stopped doing this for other reasons or not interested............................ 6

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

All of the time.............. 1

Most of the time...................... 2

Some of the time.................... 3

A little of the time...................... 4

None of the time................. 5

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

All of the time............. 1

Most of the time..................... 2

Some of the time.................. 3

A little of the time..................... 4

None of the time................. 5

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

All of the time............. 1

Most of the time..................... 2

Some of the time.................. 3

A little of the time..................... 4

None of the time................. 5

20. Because of my eyesight, I stay home most of the time:

definitely true............................. 1

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

not sure............................................. 3

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

definitely false.......................... 5

21. I am often annoyed and frustrated because of my vision problems:

definitely true............................. 1

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

not sure............................................. 3

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

definitely false.......................... 5

22. Because of my eyesight, I have much less control over what I do:

definitely true............................. 1

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

not sure............................................. 3

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

completely untrue........................... 5

23. Because of my eyesight, I have to rely too much on what other people tell me:

definitely true............................. 1

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

not sure............................................. 3

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

completely untrue........................... 5

24. Because of my eyesight, I frequently need help from other people:

definitely true............................. 1

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

not sure............................................ 3

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

completely untrue........................... 5

25. I worry that because of my eyesight, I might do something that will embarrass myself or others:

definitely true............................. 1

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

not sure............................................ 3

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

completely untrue........................... 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.