Refractive errors

CLINICAL PROTOCOL FOR DIAGNOSIS AND TREATMENT

METHODS, APPROACHES AND DIAGNOSTIC PROCEDURES [1,2,10,16] 2.1 Diagnostic criteria: Complaints and medical history [1,2,10-13]: Complaints: • in myopia: gradual painless decrease in distance vision; • in hypermetropia: decreased visual acuity, visual fatigue,

manifested by discomfort, eye pain, headache; • in astigmatism: decreased vision, visual fatigue. Medical history: • the above complaints have been present since birth or for a certain

period of time; • optical correction improves visual functions; • presence of hereditary predisposition (in parents and/or

first-line relatives – presence of myopia, hypermetropia, astigmatism). • presence of concomitant and previously suffered diseases (eye diseases,

general somatic diseases). • previously performed surgical interventions on the visual organ. Physical examination:

General examination: correct position of the eyes, full range of eyeball movements, convergence to the tip of the nose.

Laboratory tests: none.

Instrumental examinations: Basic [1,2,5,7,9-11,13,16–18]: 1) Visual acuity determination (visometry): using special tables with optotypes, UCVA, visual acuity with current optical correction, BCVA of each eye are determined; 2) Autorefractokeratometry: measurement of corneal refraction, total eye refraction (with and without cycloplegia), pediatric autorefractometers are used in infants and young children;

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3) Retinoscopy in children (with trial lenses / skiascopic rulers): retinoscopy under cycloplegia is the world standard for determining objective refraction in children; 4) Biomicroscopy: examination of optical media, anterior and posterior segments of the eyes using a slit lamp; 5) Ophthalmoscopy: examination of the fundus, condition of the optic disc, retina and retinal vessels. Additional [1,2,5,7,9-11,13,16,17]: 1) Dynamic retinoscopy with trial lenses: in hypermetropia in children allows assessment of accommodation (accommodative response, its stability) [1,2]. 2) Examination of the peripheral fundus using Goldmann three-mirror lens or non-contact wide-field fundus lens [3-8]. 3) Ultrasound or optical biometry of the eye: determination of axial length, dynamics of axial length growth in axial myopia [1-6,10,13,17]. 4) Ultrasound (B-scan) of the eye: pathological conditions of intraocular structures. 5) Tonometry – measurement of intraocular pressure in at-risk patients, when glaucoma is suspected or present as a concomitant condition [7,8]. 6) Determination of central corneal thickness – for correlation with intraocular pressure [1,2,11-16]. 7) Perimetry: visual field examination in glaucoma, in changes of the optic disc, retina, pathological myopia (diagnostic examination, monitoring changes over time) [3-8]. 8) Gonioscopy: in hypermetropia with risk of angle-closure glaucoma (short axial length with relatively large lens and narrow anterior chamber angle) [9, 10]. 9) OCT of the anterior segment of the eye [1,15-17]. 10) OCT of the posterior segment in pathological myopia, in changes of the optic disc, retina (diagnostic examination, monitoring changes over time) [18]. 11) Keratotopography [10,13-16]: • three-dimensional image of corneal surface curvature in patients undergoing orthokeratology treatment; • topo- and tomographic assessment of corneal condition using rotational Scheimpflug camera - corneal morphometric parameters and complete assessment of the anterior segment of the eye in astigmatism, corneal diseases (differential diagnosis, monitoring), in patients when planning refractive surgery. 12) Multifunctional optical biometry when planning refractive surgery for more detailed analysis - determination of axial length, keratometry, anterior corneal surface topography, anterior chamber depth, pupillometry, white-to-white, lens thickness, central corneal thickness [10,14-17].

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13) Corneal endothelial microscopy – determination of endothelial cell density [10,12,15]. 14) Fluorescein angiography of the fundus – allows assessment of myopic CNV activity [3-6]. 15) Diagnostic and navigation systems are used when planning refractive surgery. 16) Determination of the dominant eye. Indications for specialist consultations: Consultation with a geneticist (as indicated) when hereditary disease is suspected or present as a concomitant condition (isolated or syndromic pathology).

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Treatment effectiveness indicators: • improvement of visual functions; • absence of visual fatigue symptoms; • in axial myopia in children, stable refraction and axial length indicators over time

or slowing of myopia progression; • after refractive surgery – improvement of UCVA, absence of postoperative complications; • correct position of IOL in the posterior chamber in the capsular bag.

Approved by the Joint Commission on Quality of Medical Services

of the Ministry of Health of the Republic of Kazakhstan dated September 19, 2024, Protocol No. 214

REFRACTIVE ERRORS

INTRODUCTORY PART [1-19] 1.1 ICD-10 Code(s):

ICD-10

Code Name H 52.1 Myopia H 52.0 Hypermetropia H 52.2 Astigmatism

Date of protocol development: 2017 (revised 2023). 1.3. Abbreviations used in the protocol:

ONH

Optic nerve head

IOL

Intraocular lens

LVC

Laser vision correction

BCVA

Best corrected visual acuity

INN

International nonproprietary name of medicinal product

UCVA

Uncorrected visual acuity

OCT

Optical coherence tomography

AL

Axial length of the eyeball

ReLEx

Refractive lenticule extraction (general term for surgically identical technologies such as ReLEx SMILE, SmartSight, CLEAR and similar)

SE

Spherical equivalent of eye refraction Trans-PRK Transepithelial photorefractive keratectomy (T-PRK)

LE

Level of evidence

US

Ultrasound examination

FA

Fluorescein angiography of the fundus

PIOL

Phakic IOL PRK Photorefractive keratectomy

CLE

Clear lens extraction (phacoemulsification of clear lens)

CNV

Choroidal neovascularization

CCT

Central corneal thickness

CLEAR

Corneal Lenticule Extraction for Advanced Refractive Correction D Diopter

EDOF

IOL with extended depth of focus FemtoLASIK LASIK with femtosecond laser assistance LASEK/Epi- Laser Subepithelial Keratomileusis / surface

LASIK

laser keratomileusis

Laser in situ keratomileusis PMD Pellucid marginal corneal degeneration PTA Percent tissue altered index Index of corneal tissue affected PTA= (flap+ablation)/CCT

ReLEx SMILE

Refraction Lens Extraction SMall Incision Lenticule Extraction Microinvasive femtolaser lenticule extraction using laser

RST Residual stromal thickness SmartSight Minimally invasive lenticule extraction technology using laser

VEGF

Vascular endothelial growth factor

Protocol users: ophthalmologists, optometrists. 1.5 Patient category: adults, children. 1.6 Scale of level of evidence:

A High-quality meta-analysis, systematic review of RCTs or large RCT with very low probability (++) of systematic error, the results of which can be applied to the relevant population.

B High-quality (++) systematic review of cohort or case-control studies or high-quality (++) cohort or case-control study with very low risk of systematic error or RCT with low (+) risk of systematic error, the results of which can be applied to the relevant population.

C Cohort or case-control study or controlled study without randomization with low risk of systematic error (+), the results of which can be applied to the relevant population or RCT with very low or low risk of systematic error (++ or +), the results of which cannot be directly applied to the relevant population.

D Case series description or uncontrolled study or expert opinion.

Classification [1-3]: Classification of myopia: 1) Myopia by degree of refraction is divided into: Low myopia: at rest of accommodation SE ≤ 3.00 D; Moderate myopia: at rest of accommodation SE ≥3.25 and ≤6.00 D; High myopia: at rest of accommodation SE >6.00 D. 2) By age period of onset: Congenital; Early acquired (at preschool age);

Acquired at school age; Late acquired (in adulthood). 3) By equality or inequality of refraction magnitude in both eyes: Isometropic; Anisometropic. 4) By presence of astigmatism: With astigmatism; Without astigmatism. 5) By course, myopia is divided into: Stationary; Slowly progressive (less than 1.00 D per year); Rapidly progressive (1.00 D or more per year). 6) By presence or absence of complications: Uncomplicated Complicated The International Myopia Institute (IMI) and international expert council recommends using the following definitions to characterize myopia [2]: 1) Classification by etiology: Axial myopia - caused by excessive increase in AL; Refractive myopia - myopia caused by features of the refractive apparatus of the eye, stronger refractive power of the eye (cornea and/or lens); Secondary myopia - caused by a specific particular cause (use of medication, corneal pathology, myopizing lenticular sclerosis, nuclear cataract, pseudophakia, systemic disease, etc.) that is not a recognized population risk factor for myopia development. 2) Classification by degree of myopia: Low myopia: at rest of accommodation SE ≥ 0.50 D and <6.00 D; High myopia: at rest of accommodation SE ≥ 6.00 D; Pre-myopia: at rest of accommodation, eye refraction in children close to emmetropia (hypermetropia less than 0.75 D and myopia less than 0.50 D, when eye refraction, age and other quantifiable risk factors allow prediction of probability of myopia development. 3) Complications of myopia [2-8]: Pathological myopia: morphological changes in the posterior segment of the eye (including posterior staphyloma, myopic maculopathy, glaucoma-like optic neuropathy associated with high myopia) related to excessive elongation of AL in axial myopia, which cause loss of BCVA [2-8].

Myopic macular degeneration (MMD): vision-threatening condition,

often in high myopia – diffuse or focal (patchy) chorioretinal atrophy of the macula with or without lacquer cracks, Bruch's membrane defects, CNV, Fuchs' spot [3,6]. Categories of myopic macular degeneration (META-analysis for Pathologic Myopia Study Group) [5]: Myopic maculopathy: 0 – no myopic retinal lesions 1 – tessellated (pavement-like) fundus 2 – diffuse chorioretinal atrophy 3 – patchy (focal) chorioretinal atrophy (extrafoveal localization, smaller central Bruch's membrane defect, larger defect in the retinal pigment epithelial cell layer) 4 – macular atrophy "+" features (may be present in any category of myopic maculopathy): lacquer cracks, myopic CNV, Fuchs' spot.

Myopic traction maculopathy (MTM) [3,6]: combination of macular retinoschisis (traction-induced schisis-like fluid accumulation in the inner and/or outer retina), lamellar macular hole and/or foveal retinal detachment in high myopia, caused by tractional forces arising from interaction of cortical vitreous layers, epiretinal membrane, internal limiting membrane, retinal vessels and posterior staphyloma.

Glaucoma-like optic neuropathy (GON) [7,8]: characterized by loss of neuroretinal rim tissue in eyes with high myopia, secondarily enlarged optic disc and large parapapillary delta zone with normal intraocular pressure (IOP).

Classification of hypermetropia [9-11]: 1) According to etiology: Simple hypermetropia: hypermetropia due to short axial length or

weaker refractive power of the eye (cornea, lens). Functional hypermetropia: observed in patients with third cranial nerve palsy and internal ophthalmoplegia, paralysis of accommodation develops. Pathological hypermetropia – hypermetropia due to congenital and acquired eye diseases (microphthalmos, nanophthalmos, lens subluxation, aphakia, etc.) 2) By degree of refractive error: Low hypermetropia: SE ≤ 2.00 D. Moderate hypermetropia: SE ≥ 2.25 and ≤ 5.00 D. High hypermetropia: SE ≥ 5.25 D. 3) By accommodative status: Manifest hypermetropia – non-cycloplegic refractive value.

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Absolute hypermetropia: residual value of manifest hypermetropia that is not compensated by accommodative effort or the smallest plus lens providing BCVA.

Facultative hypermetropia: value of manifest hypermetropia that is compensated by accommodative effort, determined as the difference between manifest and absolute hypermetropia.

Latent (hidden) hypermetropia – value of hypermetropia compensated by accommodation, determined as the difference between cycloplegic and non-cycloplegic refractive values. May be the cause of asthenopic complaints.

Total hypermetropia: value of hypermetropia under cycloplegia (latent + manifest (absolute + facultative).

Classification of astigmatism [10]: 1) According to refraction of principal meridians: Simple (myopic, hypermetropic); Compound (myopic, hypermetropic); Mixed. 2) By orthogonality of principal meridians: Regular astigmatism: principal meridians are positioned at

90° angle to each other; Irregular astigmatism: principal meridians are not

positioned at 90° angle to each other. 4) By anatomical location: Corneal:

anterior (astigmatism of anterior corneal surface); posterior (astigmatism of posterior corneal surface); Intraocular (astigmatism of anterior and posterior lens surfaces). 5) By location of strong meridian: With-the-rule astigmatism: strong meridian is positioned vertically in sector ≥60° and ≤120°; Against-the-rule astigmatism: strong meridian is positioned horizontally in sector ≥ 0° and ≤30° or ≥150° and ≤180°; Oblique astigmatism: strong meridian is positioned in oblique axes in sector >30° and <60° or >120° and <150°. 6) By wavefront aberration: Low-order astigmatism: equivalent to refractive value; High-order astigmatism: secondary astigmatism of fourth-order aberration. Classification of anisometropia [10]: Anisometropia - ophthalmopathology characterized by difference in refraction between right and left eyes ≥ 1.0 D. 1) According to refraction:

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Simple anisometropia: refractive error is present in only one eye, the fellow eye has emmetropia;

Compound anisometropia: eyes have different degrees but the same type of refractive error, myopia or hypermetropia;

Mixed anisometropia: eyes have different types of refractive error, one eye has myopia, the other eye has hypermetropia.

2) By refractive difference: Low anisometropia: 1.25–2.00 D; Moderate anisometropia: 2.25–3.00 D; High anisometropia: >3.00 D.

Diagnostic algorithm [1,2,6,9,11,13,17]:

Collection of complaints, history

Visual acuity determination Autorefractokeratometry Physical examination Biomicroscopy Ophthalmoscopy Retinoscopy (in children)

Differential diagnosis and justification for additional investigations [1,2,13,15-17].

Diagnosis Keratoconus

Pellucid marginal corneal degeneration

Justification for Examinations differential diagnosis

Criteria for excluding diagnosis

Degenerative, non-inflammatory, bilateral (asymmetric) eye disease manifesting as progressive corneal deformation. Accompanied by progressive vision decline, refractive changes, increasing astigmatism. The disease begins in childhood and adolescence, slowly progresses until 30-40 years, and then its development stops Degenerative non-inflammatory corneal disease accompanied by characteristic thinning of the peripheral cornea in the lower segment. The disease is bilateral, often asymptomatic. May be accompanied by progressive vision decline due to irregular astigmatism.

Visual acuity determination Autorefractometry Biomicroscopy Keratotopography (assessment of corneal condition using rotational Scheimpflug camera)

of the anterior segment of the eye Visual acuity determination Autorefractometry Biomicroscopy Keratotopography (assessment of corneal condition using rotational Scheimpflug camera)

of the anterior segment of the eye Keratometry: no increase in corneal curvature Biomicroscopy: no characteristic stromal thinning, visible nerve endings in the cornea, endothelial reflex not enhanced, no Fleischer rings, Vogt's lines detected.

Keratotopography: no characteristic pattern with corneal thinning Biomicroscopy: no characteristic area of corneal thinning in the periphery from 4 o'clock to 8 o'clock Keratotopography: no characteristic pattern with peripheral corneal thinning, regular astigmatism 11 Keratoglobus

Accommodation spasm (pseudomyopia) Rare non-inflammatory globular ectasia of the cornea, often due to genetically determined elastin synthesis deficiency.

The pathological process is accompanied by refractive error (myopia, astigmatism), increased corneal curvature, increased axial length of the eye.

May be an isolated disease or syndromic Acute pathological excessive tone of accommodation, accompanied by myopization of manifest refraction and decreased BCVA.

Usually occurs in children 12-18 years old.

Visual acuity determination Autorefractometry / keratometry Biometry Accommodation assessment Retinoscopy under cycloplegia

Keratometry: corneal curvature not increased Biomicroscopy: no globular corneal ectasia, folds, thickening, ruptures of Descemet's membrane, cornea not thinned Keratotopography: no characteristic pattern with corneal thinning and ectasia BCVA not decreased No induced esotropia Comparable refraction with axial length

data

and keratometry

1. TREATMENT TACTICS AT THE OUTPATIENT STAGE [1,10,13,14,27,34-53]: Main goals: high visual acuity; relief of asthenopia symptoms; prevention of complications; slowing or inhibiting the progression of axial myopia. Treatment methods:

Non-pharmacological treatment; 2. Pharmacological treatment; 3. Surgical treatment.

Non-pharmacological treatment: 1. Visual regimen [13,16,17,29]

Near work at daylight or good artificial lighting, in preschool children limiting the duration of continuous near work (up to 30–40 cm) to 30 minutes, in school-age children limiting screen time outside school to 2 hours per day. Counseling patients and legal representatives regarding environmental conditions affecting vision. 2. Increasing time spent outdoors [13,17,28,30,34] In children, increasing time spent outdoors to at least 2 hours per day (or at least 14 hours per week) is the only known intervention associated with later onset and slower progression of myopia. Currently, the mechanism is explained by brighter light causing greater dopamine release from the retina, leading to slowing of axial elongation of the eyeball, which is the structural basis of axial myopia. 3. Optical correction for refractive errors [27,28,33-44] Optical correction is performed using spectacles and/or contact lenses of various types (including scleral contact lenses as indicated). Optical correction in children is prescribed based on objective refraction (retinoscopy) under cycloplegia. Hypermetropia [1,9,11,16] In infants and young children, if there is no manifest strabismus, no

associated risk factors, mild to moderate hypermetropia may not be corrected. Full correction of hypermetropia in children with accommodative esotropia In all other cases - the lowest optical correction power providing BCVA for distance. Astigmatism [1,9,11,16] In young children, astigmatism <2.0 D may not be corrected in the absence of associated high hypermetropia or myopia, significant anisometropia, strabismus. In all other cases, maximum tolerable astigmatism correction is prescribed. Myopia [1,2, 27,28,33–44]: Prescribed based on the principle of lowest optical correction power providing BCVA for distance. Full optical correction of myopia is used in children at risk for prevention of axial myopia progression - spectacles or contact lenses providing maximum visual acuity in each eye are prescribed [37,38,42-44]. In some cases (except when myopia control is required), for low myopia, spectacle correction may be used for distance (driving, etc.).

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Full myopia correction may be accompanied by excessive accommodation during near work, which may be accompanied by asthenopic complaints, induced esotropia.

In some cases, the degree of myopia may increase in low illumination, requiring increased optical correction power at night.

Optical methods for myopia progression control [33-44] Optical methods for myopia control are based on inducing peripheral

myopic defocus. orthokeratology "overnight" lenses [38-41] soft multi- and bifocal contact lenses [38, 42-44]

multifocal and perifocal spectacles (using technology of rings of highly aspheric microlenses, multiple embedded defocus segments, and others) [38, 45,46]

Accommodation therapy, device-based treatment of accommodative disorders in refractive errors [45,46] Children and adolescents with myopia show higher levels of accommodative lag

accommodation at near, increased accommodative convergence and esophoria. In addition, the effectiveness of myopia control is associated with factors of accommodation, vergence and the overall state of binocular vision.

Pharmacological treatment [47-53] 1. Atropinization for progressive axial myopia in children [47-53]

Currently, atropine is the only drug whose effectiveness in slowing myopia progression has been proven. Atropine is a non-selective M-cholinergic blocker with prolonged action. For myopia control, low-dose atropine sulfate solution is used in concentrations of 0.01%, 0.025% or 0.05% (the drug in these doses can be prepared in pharmacy compounding departments by prescription). Therapy is carried out by daily instillation of low-concentration atropine sulfate into the conjunctival sac at night for a prolonged period. Low-dose atropinization may be the method of choice in children aged 2–15 years with rapidly progressive myopia. Instillation of low-dose atropine may be continued, if necessary, until the child reaches 18 years of age.

When atropine therapy is discontinued, in some cases regression of the achieved myopia control may occur, the so-called "rebound effect" (more rapid progression of myopia compared to the initial level).

List of essential medicines [1,28,50]:

Pharmacotherapeutic INN Drug group

Method of administration 14 Short-acting M-cholinergic blocker Tropicamide Eye drops 1% - C 5 ml bottle.

Instill into the conjunctival sac 1-2 drops.

Prolonged-action M-cholinergic blocker Cyclopentolate Eye drops 1% - C 5 ml bottle.

Non-selective alpha-adrenergic agonist.

Phenylephrine Eye drops 2.5% - C 5 ml bottle.

M-cholinergic blocker + alpha-adrenergic agonist Phenylephrine + Tropicamide Eye drops 50mg + C 8mg/1ml.

Instill into the conjunctival sac 1-2 drops 15

minutes before the procedure or

surgery.

List of additional medicines: [1,12,14,15,18-26,28,47–53,98,99]

Method of administration LE group Prolonged-action M-cholinergic blocker Atropine sulfate Eye drops 1mg/1ml, A 1% solution – 5 ml bottle Instill into the conjunctival sac 1-2 drops Antibacterial drug of the fluoroquinolone group Levofloxacin Eye drops 5mg/1 ml C

• 5 ml bottle

Instill into the conjunctival sac 1-2 drops up to

times daily.

Antibacterial drug of the fluoroquinolone group Moxifloxacin Eye drops 5mg/1ml B

• 5 ml bottle.

15 Instill into the conjunctival sac 1-2 drops 3 times daily.

Glucocorticosteroid Dexamethasone Eye drops 1mg/1ml C Instill into the conjunctival sac 1-2 drops 3-5 times daily.

Glucocorticosteroid Dexamethasone Solution for injection, 4 C mg/ml, 1.0 ml ampoule Subconjunctival or parabulbar injection 0.5 – 1.0 ml, once daily.

Nonsteroidal anti-inflammatory drug for topical use in ophthalmology Bromfenac Eye drops 0.09% - C 5 ml bottle.

Instill into the conjunctival sac 1 drop once daily.

Nonsteroidal anti-inflammatory drug for topical use in ophthalmology Nepafenac Eye drops 0.1% - C 5 ml bottle.

Instill into the conjunctival sac 1 drop 3 times daily.

Nonsteroidal anti-inflammatory drug for topical use in ophthalmology Diclofenac sodium Eye drops 0.1% - C 5 ml bottle.

Instill into the conjunctival sac 1 drop 3-4 times daily.

Moisturizing ophthalmic solution Sodium hyaluronate Eye drops, bottle C Instill into the conjunctival sac 1-2 drops as needed.

Local anesthetic Proxymetacaine Eye drops 0.5% - C 15 ml bottle.

Instill into the conjunctival sac. Used 16 Local anesthetic Oxybuprocaine for local anesthesia during contact examination methods, refractive surgery Eye drops 0.4% - C 5 ml bottle Instill into the conjunctival sac. Used for local anesthesia during contact examination methods, refractive surgery

In the postoperative period, local antibacterial and anti-inflammatory therapy is recommended: ophthalmic forms (eye drops) of antibiotics (fluoroquinolones, aminoglycosides), glucocorticosteroids (dexamethasone, prednisolone), NSAIDs, periocular injections (as indicated).

Antibacterial drugs (fluoroquinolones, aminoglycosides). Instillation of antibacterial eye drops significantly reduces the risk of acute postoperative endophthalmitis [17,18].

Nonsteroidal anti-inflammatory drugs (NSAIDs) (bromfenac, nepafenac, diclofenac). Ophthalmic forms of NSAIDs are used to reduce pain syndrome and photophobia after keratorefractive surgery, prevention and treatment of postoperative chronic cystoid macular edema after PIOL implantation, phacoemulsification with IOL implantation, in the presence of risk of increased intraocular pressure, risk of exacerbation of herpesvirus eye lesions, presence of contraindications to the use of glucocorticosteroids [21-23].

With high risk of developing postoperative cystoid macular edema, preoperative prescription of ophthalmic forms of NSAIDs is possible, and in the postoperative period combined therapy with glucocorticosteroids and NSAIDs [21-23].

The regimen and duration of treatment are established individually depending on the severity of the condition and features of the clinical course.

LASIK);

laser intrastromal keratomileusis; laser intrastromal keratomileusis with femtolaser assistance; refractive lenticule extraction; 2. Phakic IOL implantation 3. Phacoemulsification of clear lens with IOL implantation (monofocal, toric, multifocal or EDOF). Indications for refractive surgery: 1) social (patient's desire to be free of glasses and contact lenses,

improve quality of life); 2) medical (intolerance to traditional optical correction – presence of

objective and subjective symptoms that limit the application of one or another correction method); 3) professional (necessity to have high visual functions without correction for admission to work, study). Most optimal indications for refractive surgery Laser vision correction Photorefractive keratectomy: myopia ≤ 6.00 D, in some cases up to 8.00 D by defocus equivalent astigmatism ≤ 3.00 D. LASIK / FemtoLASIK myopia up to 12.00 - 13.00 D by SE with PTA ≤40% hypermetropia not more than 5.00 D by SE corneal thickness not less than 480 μm, (with corneal thickness 480-500 μm it is safely possible to correct myopia ≤ 5.00 D by defocus equivalent) RST ≥300 μm, with PTA index ≤40% Refractive lenticule extraction myopia ≤ 10.00 D astigmatism ≤ 6.00 D pachymetry ≥500 μm RST ≥280 μm Phakic IOL implantation stable myopia from 4.00 D to 20.00 D with or without astigmatism; anterior chamber depth from endothelium to anterior lens capsule ≥ 3.0 mm; endothelial cell density ≥2000/mm2. Phacoemulsification of clear lens with IOL implantation significant refractive anomalies (high hypermetropia, high myopia, astigmatism, including mixed) in patients over 40–45 years; hypermetropia, compound hypermetropic astigmatism in persons at risk of developing angle-closure glaucoma (short axial length with relatively large lens and narrow anterior chamber angle); presbyopia Absolute contraindications for laser vision correction:

unstable refraction; corneal diseases (keratoconus, PMD, other corneal ectasias,

neurotrophic keratitis, herpetic keratitis, extensive vascularization, etc); insufficient corneal thickness for the intended volume of intervention; active uncompensated ocular surface disease (e.g. dry eye syndrome, blepharitis, atopy/allergy, etc); uncompensated glaucoma; cataract (optically significant); uncompensated autoimmune or other immune-mediated diseases; unrealistic patient expectations, mental illnesses accompanied by disturbances in perception of reality and behavioral changes. Relative contraindications for laser vision correction: age under 18 years (exception – presence of professional indications, provided refraction is stable, with myopia not more than 3.00 by SE); abnormal corneal topography/tomography indicating possible keratoconus; inflammatory diseases of the cornea, ocular surface (history of herpetic keratitis, dry eye syndrome, etc); diseases of the uvea, retina and optic nerve (uveitis, retinal vascular diseases, macular dystrophies, retinal detachment, etc); systemic autoimmune or other immune-mediated diseases; diabetes mellitus; pregnancy (laser vision correction is not an indication for termination of pregnancy) and lactation; use of retinoids for systemic therapy of acne (Isotretinoin), it is recommended to discontinue the drug 3 months before laser vision correction and resume no earlier than 6 months after laser vision correction; use of certain medications (amiodarone, colchicine, sumatriptan, levonorgestrel implants); only seeing eye. Absolute contraindications to phakic IOL implantation: unstable refraction; anterior chamber depth from endothelium to anterior lens capsule less than 3.0 mm; endothelial corneal dystrophies, endothelial cell density <2000/mm2; glaucoma; cataract; active uncompensated ocular surface disease (e.g. dry eye syndrome, blepharitis, atopy/allergy, etc);

active or recurrent inflammatory diseases of the eye (uveitis, keratitis, etc.);

active diseases of the retina and optic nerve (vascular diseases of the retina, retinal detachment, macular dystrophies);

uncompensated autoimmune or other immune-mediated diseases;

unrealistic patient expectations, mental illnesses accompanied by disturbances in perception of reality and behavioral changes.

Relative contraindications to phakic IOL implantation: age under 18 years only seeing eye; pregnancy and lactation; systemic autoimmune or other immune-mediated diseases diseases of the choroid, retina and optic nerve (history of uveitis, vascular diseases of the retina, macular dystrophies, retinal detachment, etc.); ocular surface disease (e.g. dry eye syndrome, scarring changes, etc.); diabetes mellitus. Absolute contraindications to phacoemulsification of clear lens with IOL implantation: endothelial corneal dystrophies, endothelial cell density <2000/mm2; active uncompensated ocular surface disease (e.g. dry eye syndrome, blepharitis, atopy/allergy, etc.); active uncompensated inflammatory disease of the eye (uveitis, keratitis, etc.); active diseases of the retina and optic nerve (vascular diseases of the retina, retinal detachment, macular dystrophies, etc.); uncompensated autoimmune or other immune-mediated diseases; unrealistic patient expectations, mental illnesses accompanied by disturbances in perception of reality and behavioral changes. Relative contraindications to phacoemulsification of clear lens with IOL implantation: predicted postoperative visual acuity below 0.3-0.4 (for multifocal IOLs); pregnancy and breastfeeding period; only seeing eye (exception - presence of risk of developing angle-closure glaucoma - short axial length with relatively large lens and narrow anterior chamber angle);

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autoimmune or other immune-mediated diseases; diabetes mellitus; inflammatory diseases of the eyes (history of uveitis, keratitis, etc.); diseases of the retina and optic nerve (vascular diseases of the retina, retinal detachment, macular dystrophies, etc.). 3.4 Further management [50-96,98,99]. 1. In the early postoperative period after refractive surgery, instillation of antibacterial, anti-inflammatory or combined and moisturizing ophthalmic preparations into the conjunctival cavity is indicated. The regimen and duration of local therapy is determined by the characteristics of the surgical intervention and the clinical picture in the postoperative period; 2. In the presence of concomitant disease, monitoring by a specialist; 3. Scheduled follow-up examinations with an ophthalmologist after 1 month, then at intervals of 1-2 times per year: All patients - monitoring of visual acuity, refraction, tonometry, biomicroscopy, fundus examination; After laser keratorefractive surgery – additionally keratotopography as indicated; After phakic IOL implantation – additionally monitoring of endothelial cell density, phakic IOL position; After phakic IOL implantation and phacoemulsification of clear lens with IOL implantation – examination of the fundus periphery using Goldmann three-mirror lens or non-contact wide-field fundus lens - performed 1 month after surgery, then 1-2 times per year or more frequently as indicated. 4. Patients after successfully performed refractive surgery may require additional spectacle correction for distance and/or near (due to physiological age-related accommodation features in the form of presbyopia; functional-optical features of IOLs in aphakia). 5. Some aspects of refractive surgery are presented in Appendix 1.

TREATMENT TACTICS AT INPATIENT LEVEL: 5.1. Non-pharmacological treatment (regimen, diet): - general regimen; - diet table No. 15 (in the absence of contraindications). 5.2 Pharmacological treatment: see section 3.2. 5.3 Surgical intervention: see section 3.3. 5.4 Further management: see section 3.4. 5.5 Indicators of treatment effectiveness: see section 3.5.

ORGANIZATIONAL ASPECTS OF THE PROTOCOL 6.1 List of developers: 1. Tuletova Aigerim Serikbaevna – Candidate of Medical Sciences, Director of the

Branch of the Kazakh Research Institute of Eye Diseases, Astana. 2. Kim Olga Robertovna – Candidate of Medical Sciences, Head of the Department of Refractive Surgery of the Kazakh Research Institute of Eye Diseases, Almaty. 3. Kim Vladimir Ukhenovich – Candidate of Medical Sciences, General Director of the "Astana Vision" clinic network, Astana. 4. Begimbaeva Gulnara Enbekovna – Doctor of Medical Sciences, General Director of the "Focus" Ophthalmological Center, Almaty. 5. Baimukhanova Elena Bakhtiyarovna - Candidate of Medical Sciences, Director of "GlazoLik Ophthalmology Center" LLP, Karaganda. 6. Mukazhanova Ainagul Serikovna – Deputy Head of the Postgraduate Education Department of the Kazakh Research Institute of Eye Diseases, Astana. 7. Panchenko Snezhana Konstantinovna – Candidate of Medical Sciences, Medical Director of "Astana Vision" clinic in Astana. 8. Abilmazhinova Aliya Amangeldiievna – Clinical Pharmacologist, Kazakh Research Institute of Eye Diseases, Almaty.

List of reviewers:

22

Suleimenov Marat Smagulovich – Doctor of Medical Sciences, Professor, Head of the Department of Ophthalmology of the Kazakh National Medical University, Almaty.

Conditions for protocol revision: revision of the protocol 5 years after its development or in the presence of new methods with level of evidence.

Presence of conflict of interest: none.

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Appendix 1 Myopia control is a group of measures aimed at preventing the development of myopia in children at risk, slowing the progression of axial myopia, and preventing complications. For children at high risk of developing myopia, preventive measures should be initiated even before the manifestation of myopia. Myopia control includes: visual regimen, increasing time spent outdoors, reducing screen time; full optical correction; use of optical methods of myopia control; low-dose atropinization. In the presence of initially thin cornea and/or significant volume of planned myopia correction with predicted borderline RST value and/or in the presence of some abnormal-borderline topography/tomography parameters of the cornea, but without clinical signs of keratectatic diseases (keratoconus, PMCD), the possibility of LKZ with simultaneous performance of prophylactic/preventive corneal collagen crosslinking is considered individually [62 - 78]. In rare cases during LZK surgery, formation of an opaque bubble layer, vertical gas breakthrough, loss of vacuum fixation requiring cessation of surgery, change of plan to another type of surgery, as well as flap displacement, flap loss, decentration of laser exposure, lenticule tear with presence of lenticule remnants in the interface are possible [1, 10, 13, 55 - 58]. The "monovision" principle implies that the patient's dominant eye is corrected for distance vision, and the paired non-dominant eye for near vision. Monovision is not recommended for patients with strabismus, amblyopia, glaucoma (visual field defects present), macular degeneration (decreased central vision), if professional activity or lifestyle requires ideal binocular vision [1,9,10]. The "minimonovision" principle implies that, preferably, the patient's dominant eye is corrected for distance vision, and the paired non-dominant eye for near vision, with induced anisometropia in the form of myopic refraction not exceeding -0.50 ÷ -0.75 D, with preservation of binocular vision. This approach can be used when planning LKZ, especially in persons aged around 40 years and older, as well as when planning intraocular refractive surgery. Determination of the dominant (leading, functionally predominant in the process of binocular vision) eye when planning refractive surgery may be one of the factors influencing patient satisfaction with monovision. Cases of "undercorrection" or "overcorrection" after refractive surgery may require additional intervention for the purpose of enhancement (for example, LKZ) or use of additional optical correction. In cases of initially very high degrees of refractive error, according to indications, sequential combined use of LKZ and intraocular surgery is possible [80-89].

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As indicated:

Dynamic retinoscopy Ultrasound or optical biometry of the eye Examination of the peripheral fundus Ultrasound B-scan Tonometry Determination of central corneal thickness OCT of the anterior / posterior segment of the eye Perimetry

Refractive surgery (as indicated):

Keratotopography (assessment of corneal condition using rotational Scheimpflug camera) Tonometry Multifunctional optical biometry Examination of the peripheral fundus Endothelial microscopy Gonioscopy OCT Determination of the dominant eye

In pathological myopia (as indicated):

OCT of the posterior segment of the eye Examination of the peripheral fundus Biometry of the eye Tonometry Determination of central corneal thickness Perimetry FAG

In hypermetropia with risk of glaucoma development (as indicated):

Tonometry Determination of central corneal thickness Perimetry Gonioscopy OCT of the anterior / posterior segment of the eye

Fig. 1. Algorithm for diagnostic examination of patients with refractive errors.

10

Surgical intervention [12,14,50-96]. Microsurgical operations aimed at correcting refractive errors (refractive surgery): 1. Keratorefractive - laser vision correction: photorefractive keratectomy (including T-PRK/Trans-PRK, LASEK/Epi-

INDICATIONS FOR HOSPITALIZATION WITH INDICATION OF TYPE OF

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HOSPITALIZATION. 4.1 Indications for planned hospitalization: cases of phacoemulsification of clear lens with IOL implantation in high-risk individuals: significant refractive errors (high hypermetropia, extremely high myopia) in patients over 40–45 years of age, hypermetropia with risk of angle-closure glaucoma development (short axial length with relatively large lens and narrow anterior chamber angle), presence of concomitant systemic diseases (as indicated). 4.2 Indications for emergency hospitalization: none