Full-thickness macular hole and vitreomacular traction syndrome: clinical guidelines

List of Abbreviations

VMA – vitreomacular adhesion

VMTS – vitreomacular traction syndrome

ILM – internal limiting membrane

VE – vitrectomy

PHM – posterior hyaloid membrane

PVD – posterior vitreous detachment

IMH – idiopathic macular hole

LMH – lamellar macular hole (partial macular defect)

ICD – International Classification of Diseases

BCVA – best corrected visual acuity

MH – macular hole

NRL – neurosensory retinal layer

OCT – optical coherence tomography

AL – axial length of the eye

RPE – retinal pigment epithelium

FTMH – full-thickness macular hole (full macular defect)

EMF – epimacular fibrosis

Terms and Definitions

Ocular biomicroscopy — a method of in vivo visual examination of the optical media and structures of the eye, based on creating contrast between illuminated and non-illuminated areas, performed using a slit lamp and additional diagnostic lenses (in particular, for fundus biomicroscopy).

Vitrectomy — an endovitreal surgical intervention aimed at removing the vitreous body and relieving vitreoretinal tractions.

Vitreomacular adhesion (VMA) — a physiological state characterized by a connection between the retina and the posterior hyaloid membrane (PHM) in the macular area, while tractional changes of the vitreomacular interface are absent

Vitreomacular interface — the contact area between the posterior hyaloid membrane and the internal limiting membrane of the retina in the macula region.

Vitreomacular traction syndrome (VMTS) is a chronic condition associated with incomplete posterior vitreous detachment (PVD) and preretinal proliferation, which cause tractional deformation of the macula, mechanical tension, and damage to the macular area of the retina.

Lamellar macular hole (LMH) / incomplete macular hole is a non-full-thickness defect of the inner retinal layers in the foveal region, which is identified during biomicroscopy as a round or oval, well-demarcated reddish spot. Tractional and degenerative LMH are distinguished.

Full-thickness macular hole (FTMH) / complete macular hole is an acquired condition representing a full-thickness defect of the foveal part of the retina from the internal limiting membrane to the level of the retinal pigment epithelium (RPE).

Optical coherence tomography (OCT) is a non-invasive in vivo imaging technology that provides high-resolution tomographic cross-sections of intraocular structures.

Epiretinal membrane (ERM) is a pathological condition characterized by the appearance of an epiretinal proliferative membrane on the surface of the internal limiting membrane (ILM), leading to deformation of the retinal surface in the macular zone.

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Full-thickness macular hole / complete macular hole is an acquired condition representing a full-thickness defect of the foveal part of the retina from the internal limiting membrane to the level of the retinal pigment epithelium [1, 2].

Vitreomacular traction syndrome (VMTS) is a chronic condition associated with incomplete PVD and preretinal proliferation, which cause tractional deformation of the macula, mechanical tension, and damage to the macular retina [3].

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

Since the mid-20th century, various scientists have suggested that VMTS is a direct cause of FTMH formation; however, prior to the advent of OCT, the validity of this hypothesis was difficult to prove due to the lack of in vivo imaging capabilities for morphological structures of the vitreomacular interface. In 1952, the results of a study were published demonstrating the existence of such a pathogenetic element as pathological adhesion of the posterior hyaloid membrane (PHM) to the ILM in the foveal zone of the retina [4]. Subsequently, numerous studies were conducted, confirming the primary and paramount role of VMTS in the formation of FTMH [5, 6, 7]. Today, due to the widespread introduction of OCT into ophthalmological practice, the pathogenesis and biomechanics of FTMH formation have become clear thanks to the ability to visualize the morphological features of the vitreoretinal interface and the dynamics of their changes. The pathogenesis of FTMH is based on pathological adhesion of the PHM to the ILM in the foveal and parafoveal zones of the macula. Further, as a result of active PVD, traction is exerted on the retinal surface in the areas of PHM adhesion; the next stage involves the formation of intrafoveal microstructural changes, which subsequently transform into a tractional retinal cystoid space in the area of tension. In the case of weaker adhesive properties of the PHM, spontaneous separation may occur while maintaining the anatomical integrity of the retina; however, if the attachment of the PHM to the ILM is tight, the probability of FTMH formation is high. Thus, it can be concluded that FTMH represents the terminal stage of VMTS [8, 9, 10, 11].

1.3 Epidemiology of the Disease or Condition

The incidence of macular holes (MH) is 3.3 per 1,000 individuals in the age group over 65 years [12]. In 19% of cases, it is bilateral [13]. The prevalence of FTMH in the US is 7.8 individuals per 100,000 population per year. The female-to-male ratio is 3.3:1 [14].

Risk factors for the development of FTMH are female sex and age over 65 years [15].

1.4 Features of Coding the Disease or Condition

H35.3 - Macular and posterior pole degeneration.

1.5 Classification of the disease or condition

According to etiology, FTMH can be divided into primary (idiopathic), which form as a result of traction on the foveal zone from the vitreous body, and secondary (traumatic, associated with high myopic complications, epiretinal membrane, neovascular membrane) [16].

According to size, FTMHs are divided into: small (up to 250 µm), medium (250–400 µm), and large (more than 400 µm). The size of the hole can influence the probability of FTMH closure after surgical treatment and determines the functional prognosis [17].

1.6 Clinical presentation of the disease or condition

Primary "idiopathic" FTMHs

Before the advent of OCT, the main method for diagnosing macular holes was ophthalmoscopy, which remains a leading method for their initial detection today.

In 1988, R.N. Johnson and J.D. Gass proposed a classification of FTMH reflecting its evolution during development, based on ophthalmoscopic data, assuming that the leading role in the formation of idiopathic macular holes belongs to vitreoretinal tractions [18, 19]. In 1995, this classification was updated taking into account data obtained using OCT. Thus, the J.D. Gass classification includes the following stages of development of idiopathic FTMH:

Stage 1A: yellow spot (serous detachment of the fovea)

Stage 1B: yellow ring, loss of foveal reflex

Stage 1C: eccentric retinal defect within the yellow ring (formation of a pseudoperculum)

Stage 3: ring of opaque foveal retina (hole with a pseudoperculum, without vitreous detachment)

Stage 4: central circular defect, Weiss ring (hole with a pseudoperculum, complete PVD).

With the introduction of OCT into clinical practice, new possibilities emerged in the diagnosis of FTMH. Based on OCT findings, the International Vitreomacular Traction Study (IVTS) Classification Group developed a classification in 2013 of macular diseases caused by vitreous traction [17]. The following conditions were identified: vitreomacular adhesion (VMA), vitreomacular traction syndrome (VMTS), and FTMH. This classification allows for determining the prognosis of the disease course and surgical intervention outcomes. VMA and VMTS are subdivided into focal (adhesion width <1500 µm) and broad (adhesion width >1500 µm), as well as isolated or associated with concomitant ocular pathology (age-related macular degeneration, diabetic macular edema, retinal vein occlusion). According to size, FTMHs are subdivided into small (<250 µm), medium (250–400 µm), and large (>400 µm).

Table 1 shows the comparison of the ophthalmoscopic picture and OCT data in primary MHs, as well as the correspondence between the classifications by J.D. Gass and IVTS.

Secondary FTMHs

Traumatic FTMHs usually occur due to sudden axial compression of the eye resulting from mechanical impact leading to equatorial expansion and FTMH formation. FTMH can be combined with other fundus lesions, such as choroidal or Bruch's membrane rupture, retinal detachment, sclopetaria, or peripheral tears. The visual prognosis depends not only on the closure of the FTMH but also on the topography of other lesions. If the choroidal rupture passes through the foveal area or if post-contusional RPE atrophy involves the fovea, the visual prognosis will be poor. Unlike idiopathic FTMHs, PVD does not occur in traumatic ones. Surgical intervention is usually effective, but traumatic FTMH may also occasionally close spontaneously within the first weeks after its occurrence [20].

FTMHs are one of the complications of high myopia along with posterior staphyloma and choroidal atrophy. Their pathogenesis may differ from that of FTMHs in non-myopic eyes, as the PHM often remains fixed to the retinal surface. Some of these FTMHs occur after progressive foveoschisis. Others may be asymptomatic and detected only during fundus OCT examination. Despite surgical treatment with removal of the PHM and ILM, the anatomical and visual postoperative prognosis for FTMH in high myopia remains less favorable than for idiopathic FTMHs [20].

Secondary FTMHs can sometimes result from the following causes: Alport syndrome, Behçet's disease, Best macular dystrophy, cat-scratch disease, central retinal artery occlusion, drusen, electrical injury, fungal endophthalmitis, idiopathic parafoveal telangiectasia, laser pointer exposure, Nd:YAG laser injury, Nd:YAG posterior capsulotomy, retinal artery macroaneurysm, retinitis pigmentosa, Stargardt disease, chorioretinitis (syphilitic or toxoplasmic etiology), Valsalva retinopathy, vitrectomy, Vogt-Koyanagi-Harada disease, and X-linked juvenile retinoschisis [20].

Differential diagnosis

FTMH requires differential diagnosis with lamellar macular hole (LMH) and macular pseudohole, as they have similar ophthalmoscopic features.

Lamellar macular hole / partial macular hole is a non-full-thickness defect of the inner retinal layers in the foveal region, which is identified during biomicroscopy as a round or oval, well-demarcated reddish spot. OCT features of LMH include: irregular foveal contour, defect of the inner retinal layers, foveoschisis (most commonly between the outer plexiform and outer nuclear layers), and an intact photoreceptor layer. A. Govetto et al. (2016) classified LMH into 2 types based on their pathogenesis: tractional and degenerative, using OCT data [21].

Degenerative LMH is characterized by apparent tissue loss in the foveolar pit (often with overhanging edges), an ellipsoid zone defect, epiretinal proliferation, and central foveal mounding, forming a "top hat" sign (Figure 1, top). Tractional LMH is characterized by a-shaped intraretinal splitting, an intact ellipsoid zone, tractional epiretinal membranes, and intraretinal cystic spaces with a "stout" sign (Figure 1, bottom).

Figure 1. Comparative OCT in LMH (A. Govetto, 2016). Description in the text.

Macular pseudohole is a condition that often mimics FTMH, although by its mechanism of development, it is a specific variant of ERM [22, 23]. On ophthalmoscopy, pseudoholes resemble stage 2–3 FTMH; however, visual impairment may be absent, or visual acuity may be better than in FTMH. For differential diagnosis between FTMH and pseudohole during ophthalmoscopy, the Watzke-Allen test can be useful: a vertical and then horizontal slit-lamp light beam, 100 µm wide, is directed at the hole area, and the patient is asked to identify any break in the light line (if a break is present, it is likely an FTMH, whereas pseudoholes and LMHs do not cause defects in the light line observed by the patient). OCT is the primary diagnostic imaging method that allows differentiation between FTMH, LMH, and pseudohole [24].

OCT criteria for pseudohole: 1) an epiretinal membrane that does not involve the central fovea; 2) retinal thickening in the macular area; 3) a vertical or steep foveal profile; 4) presence of microcysts in the inner nuclear layer of the retina; 5) near-normal central foveal thickness [25].

2. Diagnostics, medical indications and contraindications for diagnostic methods

The most important factor in determining the correct treatment strategy for patients with a macular hole is the diagnostic differentiation between full-thickness (idiopathic) and non-full-thickness (lamellar) MH, determination of the hole diameter, and correlation of anatomical and functional changes in the central retina (Table 1).

Table 1. Correlation of primary MH classifications

2.1 Complaints and Anamnesis

Comments: At stage 0 FTMH, when vitreomacular interface changes are present without alterations in retinal morphology and architecture, clinical parameters may remain unchanged for a long time with a lack of subjective symptoms. Among the earliest symptoms as the process progresses are changes in central vision: metamorphopsia is the primary complaint, with patients noting distortion of object contours and bending of straight lines. Decreased visual acuity is the second most common complaint. Appearance of a spot before the eye (central scotoma) is also a frequent complaint during the development of FTMH. Anatomically, this subjective sensation is associated with the absence of retinal tissue in the foveolar area [16].

When taking an anamnesis, the ophthalmologist should pay attention to the following: advanced age, established diagnosis of "epiretinal membrane" (epiretinal fibrosis), high myopia, eye trauma, history of hydrodynamic shock (as a hydrodynamic wave passing through the eyeball can form tears, including in the macular area), and previous ophthalmic surgeries. FTMH can develop after various ophthalmic surgeries in up to 1% of cases, and after rhegmatogenous retinal detachment surgeries in up to 3% of cases [16].

2.2 Physical Examination

Comments: patients with concomitant, including systemic, diseases and risk factors for various complications should be referred to relevant specialists for consultation prior to laser or surgical treatment in order to identify potential contraindications to these treatment modalities and minimize the risk of complications. The specialty of the physician (general practitioner, otolaryngologist, dentist, endocrinologist, etc.) is determined based on the comorbid systemic disease and risk factors for systemic complications [26].

2.3 Laboratory Diagnostics

Comments: there are no diagnostic criteria for FTMH based on clinical laboratory test results.

Comments: The examination is performed based on informed consent (Sanitary and Epidemiological Rules SP 3.1.5.2826-10 "Prevention of HIV Infection"). The choice of laboratory tests is determined by the presence of a concomitant systemic disease and risk factors for systemic complications in the patient [32]. Additional laboratory tests are prescribed depending on the presence and clinical features of the patient's concomitant systemic disease and risk factors for systemic complications. It is recommended to refer patients with concomitant systemic diseases and risk factors for systemic complications for laboratory testing prior to laser or surgical treatment in order to identify potential contraindications to these treatments.

2.4 Instrumental Diagnostics

Comments: The ophthalmoscopic appearance of a macular hole depends on its stage of development and time of formation. In the early stages of tear (pre-tear) formation, diagnosis via fundus biomicroscopy is quite challenging. The ophthalmoscopic picture in this case is not pathognomonic. At this stage, the physician may observe a decrease or complete disappearance of the foveal reflex, or the appearance of the "yellow spot" or "yellow ring" sign. However, it should be kept in mind that the "yellow ring" sign can also occur in other ophthalmological diseases, such as traumatic (contusion) macular injury or a number of inherited dystrophies.

Central retinal defect. In a developed full-thickness macular hole, ophthalmoscopy reveals a well-defined, round or oval-shaped reddish defect of the neuroretinal layers of the retina. Yellow-whitish clusters composed of lipofuscin-laden macrophages and pigment epithelium nodular lesions with eosinophil inclusions may be present at the base of the defect. At this stage, the Watzke-Allen test can be performed, in which the examiner directs a narrow vertical strip of light—formed by the slit-lamp diaphragm—through the foveola. If the patient reports a break in the light strip, the test is considered positive. This effect is due to the absence of neurosensory tissue in the center of the hole. If the patient reports distortion or a change in the thickness of the light strip, the test is considered negative, and additional diagnostic methods are required to interpret the result.

Elevation of the hole edges. In most individuals, elevation of the hole edges is observed due to subretinal fluid and edema of the neuroretinal layers of the retina around the hole. With widespread edema, the color of the macular zone becomes duller. This is because the presence of fluid in the retinal layers shields the fundus background. Macular holes may be combined with epiretinal fibrosis, which somewhat alters the fundus appearance.

Epiretinal fibrosis. Ophthalmoscopy reveals additional pathological reflexes in the form of light glints ("cellophane macula"). In addition, corrugation of the inner retinal layers beneath the epiretinal membrane may be detected. Epiretinal fibrosis can be local or extend beyond the vascular arcades. Cystic changes at the edge of the hole are a frequent ophthalmoscopic finding.

Changes in the retinal pigment epithelium. The pigment epithelium does not undergo changes in the early stages of hole formation. In long-standing forms, areas of atrophy and hyperplasia may be detected upon ophthalmoscopy.

It is important to note that these signs occur in varying percentages in macular holes. Analysis of ophthalmoscopic data from more than 200 patients revealed the following distribution:

• disappearance of the normal foveal reflex (in 100% of cases);

• round defect with well-defined edges in the foveal zone of varying size (in 100% of cases);

• partial attachment of the posterior hyaloid membrane to the edge of the hole (in 63.3% of cases);

• complete detachment of the posterior hyaloid membrane—Weiss ring (in 37.7% of cases);

• "cellophane macula" sign (in 8.3% of cases);

• yellow inclusions around the macular hole (in 5.3% of cases);

• cystoid changes of the retina at the edges of the hole (in 75.6% of cases);

• semi-transparent tissue over the depression forming a pseudomembrane (in 82.6% of cases) [16].

Comments: OCT makes it possible to objectively differentiate between full-thickness and partial-thickness macular holes, determine hole diameter, visualize posterior vitreous detachment in early stages, as well as the presence of a preretinally located operculum, and visualize vitreo-macular tractions. This can facilitate the differentiation of idiopathic macular holes from idiopathic macular deformation caused by epiretinal fibrosis, which is characterized by complete posterior vitreous detachment and a Weiss` ring. Optical examination of the retina using a computerized analyzer is recommended to be performed under pharmacological mydriasis, as this significantly improves scan quality.

Comments. Microperimetry for assessing retinal sensitivity combined with fundus examination provides an accurate correlation between macular pathology and the corresponding functional abnormality [16, 33, 36]. In an average sample of patients with MH, light sensitivity is distributed unevenly. Specifically, light sensitivity values are 1.15-fold and 1.28-fold higher in the superotemporal and inferotemporal quadrants compared to the superonasal and inferonasal quadrants, respectively. This feature is due to the presence of the papillomacular bundle and a more sensitive zone on the nasal side, which dictates the need to preserve the internal limiting membrane (ILM) over this area. The most pronounced decrease in photosensitivity is observed in the center of the macula with the formation of an absolute scotoma, caused by the development of MH. Relatively unstable fixation is determined in 83.3% of patients with MH. A new fixation point is identified in all studied patients along the upper edge of the tear. Thus, microperimetry makes it possible to comprehensively determine the functional parameters of the central retina, which is most important for patients with MH. Changing the point of fixation of gaze is of immense value to the surgeon as it determines the choice of surgical management tactics.[16]

For self-diagnosis and home monitoring to assess metamorphopsia and central visual field defects patients may be advised to use the Amsler grid (scotometry using the Amsler-Marinchev test).

Comments: the decision to prescribe additional diagnostic examinations is made by the physician based on the results of the baseline examination

2.5 Other Procedures

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

3.1 Conservative Treatment

3.2 Laser Treatment

3.3 Surgical Treatment

Comments: The ophthalmologist referring the patient for vitreous surgery should pay attention to several points:

- the severity of pathological changes to predict the functional outcome of the surgery [46]

- the degree of lens opacity to plan staged or combined surgery (microinvasive vitrectomy or vitreoschisis surgery combined with ultrasound phacoemulsification) in case of decreased optical media transparency [46]

- the severity of the general disease, the patient's expected life expectancy, and the risk of anesthesia [43]

To perform microinvasive 23-27G pars plana posterior closed vitrectomy or vitreoschisis surgery when indicated, it is necessary to use an ophthalmic surgical system utilizing 23-27Ga sets (preferably 25Ga) for posterior vitrectomy, or combined sets [40, 41] An ophthalmic surgical microscope with magnification, focus, translational movement along two axes (X and Y), and rotational movement (gross step, tilt), contact or non-contact wide-angle visualization systems, and digital systems providing real-time intraoperative stereoscopic imaging are used. [51] A transscleral puncture is made 3-4 mm from the limbus (the distance is marked by the opposite end of the trocar having 3 and 4 mm markers) with the placement of 3 or more 23-27G valved ports and an infusion system [40, 41]. Vitreous removal in the central sections is performed using a 23-27Ga vitetome, induction of the posterior hyaloid membrane, membrane peeling, and the use of air or gas-air tamponade (temporary tamponade of the vitreal cavity with air (systems with an automatic infusion/air valve that do not require additional steps for replacement are preferred), ophthalmic gas (systems with an automatic gas filling function are preferred), and the use of ophthalmic silicone oil with a viscosity of 1000-5700 cSt.[40]

During 23-27G microincision posterior closed vitrectomy or pars plana vitreoschwartsectomy (preferably 25Ga), various techniques for macular hole closure can be performed, including the use of an internal limiting membrane flap (inverted flap, "floating" flap, "free" flap), platelet-rich autoplasma (PRP technology, ACP technology), and mechanical or vacuum approximation of the hole edges. If the transparency of optical media is reduced due to lens opacity, ultrasound phacoemulsification with intraocular lens implantation can be performed. [46, 52-54] If indicated, the following procedures may be performed: removal of silicone oil from the vitreal cavity [55], retinal endolaser coagulation [56], temporary tamponade with a perfluorocarbon compound to manipulate the internal limiting membrane flap, endodiathermocoagulation, endotamponade with an ophthalmic gas (e.g., sulfur hexafluoride, perfluoropropane) or fluorocarbon liquids followed by replacement with air, ophthalmic gas, or silicone oil with a viscosity of 1000-5700 cSt (using a universal ophthalmic surgical phaco/vitreo system for simultaneous replacement of fluorocarbon liquid with silicone or sequential replacement with air and then silicone) [55, 57] and other manipulations using a surgical ophthalmic microscope (including one coupled with a digital imaging system) [51]. Preoperative patient preparation is carried out in conjunction with a general practitioner. If necessary, consultations are prescribed with an endocrinologist (in case of diabetes mellitus), nephrologist (in case of renal impairment), cardiologist (if cardiovascular complications are present), podiatrist and/or surgeon (in case of diabetic foot syndrome). [46]

Comments: the duration of endotamponade of the vitreal cavity with silicone oil is determined by the physician based on the results of patient dynamic monitoring.[55]

During the removal of silicone oil from the vitreous cavity, a 23-27G pars plana trocar system setup is used (valved ports are preferred) [40, 41], membrane peeling may be performed [46, 53], endolaser photocoagulation of the retina using a 532 nm laser [56], endodiatermocoagulation, endotamponade with an ophthalmic gas (e.g., sulfur hexafluoride, perfluoropropane), liquid fluorocarbons (e.g., perfluoroctane), or silicone oil with a viscosity of 1000-5700 cSt.[55] If the transparency of the optical media is reduced due to lens opacification, ultrasound phacoemulsification with intraocular lens implantation and other manipulations using a surgical ophthalmic microscope, contact or non-contact wide-angle visualization systems, or a digital visualization system allowing real-time intraoperative stereoscopic imaging may be performed. [46]

Comments: the duration of instillations and injections of medicinal products before and after vitreoretinal surgery is determined by the physician based on a comprehensive assessment of the clinical picture of the disease, the course of the surgery, and the postoperative period [45, 59]

3.4 Dietary Therapy

4. Medical Rehabilitation and Sanatorium-Resort Treatment

Comments: for full psychological rehabilitation, the patient must be warned before the operation about the gradual improvement of vision in the postoperative period. With prolonged follow-up after successful surgery, macular hole visual acuity can reach maximum values within 6 months or more after the treatment [61]

5. Prevention and Dispensary Observation

Comments: The highest prevalence of macular holes was detected in the group of patients over 55 years of age, the majority of whom are women [62, 63]. The formation of a macular hole usually develops over a period of time ranging from several weeks to months through certain clinical stages, although some macular holes can develop faster [1]., therefore, clinical dispensary follow-up of patients is required (frequency is determined individually).

Evidence – 5).

Comments: High myopia, previous eye trauma, and/or surgical intervention on the organ of vision are risk factors for the development of a secondary macular hole [16, 17, 65].

Comments: An ophthalmologist performs examinations of postoperative patients once or more during the first month after treatment, taking into account the postoperative ophthalmic status. Subsequent monitoring is carried out by the local ophthalmologist once every 6–12 months to track potential late complications; the frequency and timing of subsequent postoperative visits vary depending on the surgical outcome and the presence of symptoms in the patient. In the event of an unexpected decrease in visual acuity or the appearance of any visual complaints, an examination by an ophthalmologist should be performed as soon as possible, regardless of the scheduled visit timeline [1].

Comments: The risk of MH development in the fellow eye within 5 years from the time of MH detection in the first eye is approximately 10–15%; in the presence of a complete posterior vitreous detachment, the risk decreases [63].

6. Organization of Medical Care

Issues regarding the organization of medical care for MH are primarily related to diagnostic timeliness and the possibility of performing early treatment (early treatment of MH ensures the achievement of anatomical closure of the macular hole and improves postoperative visual acuity in patients).

Primary specialized health care is provided by an ophthalmologist in the outpatient department of a medical organization.

Treatment (vitreoretinal surgery) is performed by an ophthalmologist in an outpatient setting, in a day hospital setting, or in an inpatient setting.

Indication for planned hospitalization in a medical organization:

• the need to perform surgical interventions in a day hospital or inpatient setting.

Indication for emergency hospitalization in a medical organization:

• endophthalmitis as a complication of vitreoretinal intervention [66].

Indication for patient discharge from a medical organization:

1) completion of treatment or a stage of specialized, including high-tech, medical care in an inpatient or day-care setting, provided there are no treatment complications requiring drug correction and/or inpatient medical interventions;

2) refusal of the patient or their legal representative from specialized, including high-tech, medical care in an inpatient or day-care setting;

3) need to transfer the patient to another medical organization.

7. Additional Information

It is important to explain to the patient the need to normalize hemodynamic and blood parameters (blood pressure, blood glucose levels, etc.) prior to surgical treatment of MH (especially in patients with concomitant systemic diseases and risk factors for systemic complications). It is also necessary to encourage the patient to strictly comply with all prescriptions from specialists (ophthalmologist, cardiologist, therapist, endocrinologist, etc.).

The patient must be informed about the inevitable progression of anatomical and functional changes in MH if left untreated, leading to a persistent decrease in visual acuity and the formation of a central scotoma.

The patient must understand that the effectiveness of MH treatment depends on the timely performance of surgical intervention (vitreoretinal surgery).

The patient must be informed about the need to maintain a face-down postoperative positioning for up to 3 days.

In the postoperative period, it is necessary to explain to the patient the recommended frequency of examinations by an ophthalmologist, as well as the need for unscheduled examinations if any new visual disorders appear.

In cases of irreversible low vision, the patient must have complete information on the possibilities of professional, social, and psychological rehabilitation.

In the event of vitreoretinal surgery, the following points must be discussed with the patient:

- it is important to warn the patient about the specifics of the postoperative course and possible ocular manifestations (irritation, eye redness, pronounced eyelid edema, eye discharge, pain in the eye area, foreign body sensation, or discomfort when blinking, etc.), the severity of which depends on the individual body's sensitivity to the surgical trauma.

- it is important to explain to the patient that final spectacle correction is best prescribed no earlier than 2–3 months after surgery (the timing of spectacle prescription is determined individually).

- the patient must be informed of the need for an unscheduled examination by an ophthalmologist if complaints and changes characteristic of MH occur in the operated or fellow eye.

- it is important to warn the patient about the gradual improvement of vision in the postoperative period.

- it is important to warn the patient about regimen compliance (face-down head position, temporary restriction of activity, specific bed rest requirements, frequency of eye drop instillation, restriction of air travel in case of gas tamponade) after surgery, which may have a certain therapeutic value. Individual recommendations must be clarified during the medical consultation.

- it is important to warn patients of the need to immediately report symptoms that may suggest intraocular inflammation (endophthalmitis): eye pain or increased discomfort in the eye, increased eye redness, blurred or decreased vision, increased light sensitivity, or an increase in the number of "floaters" in the visual field.

- it is important to warn the patient about the need for a second surgery to remove silicone oil (if the vitreous intervention was completed with silicone oil tamponade), and to inform the patient about the need to instill hypotensive drops into the operated eye and periodically monitor intraocular pressure until the silicone oil is removed from the vitreous cavity.

- it is important to discuss with phakic patients the possibility of cataract development in the postoperative period in the operated eye, and in the case of pre-existing cataract, to explain the option of a combined procedure.

Criteria for Evaluating the Quality of Medical Care

Table 3. Criteria for assessing the quality of medical care

References

Appendix A1. Working Group Composition

Appendix A2. Methodology for Developing Clinical Guidelines

Target audience for these clinical guidelines:

• Ophthalmologists;

• General practitioners (family physicians).

Methods used for collecting/selecting evidence: search in electronic databases; analysis of modern scientific developments on the problem of rhegmatogenous retinal detachment in Russia and abroad; synthesis of practical experience of Russian and foreign specialists. Description of methods used for collecting/selecting evidence: the evidence base for the recommendations includes publications included in the Cochrane Library, EMBASE, and MEDLINE databases, as well as monographs and articles in leading specialized peer-reviewed domestic medical journals on this topic. Methods used for assessing the quality and strength of evidence: expert consensus, significance assessment in accordance with the rating scheme.

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

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

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

Procedure for updating clinical guidelines.

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

Appendix A3. Reference Materials

1. International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). World Health Organization.

2. Nomenclature of Medical Services. Order of the Ministry of Health of the Russian Federation No. 804n dated October 13, 2017, "On Approval of the Nomenclature of Medical Services."

3. Order of the Ministry of Health of the Russian Federation No. 205n dated May 2, 2023, "On Approval of the Nomenclature of Positions of Medical Workers and Pharmaceutical Workers"

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

5. Procedure for Providing Medical Care to the Adult Population for Diseases of the Eye, its Adnexa, and Orbit. Order of the Ministry of Health of the Russian Federation 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."

6. Directive of the Government of the Russian Federation No. 2406-r dated October 12, 2019 (as amended on June 9, 2023) "On Approval of the List of Vital and Essential Medicines, as well as Lists of Medicines for Medical Use and the Minimum Assortment of Medicines Required for the Provision of Medical Care"

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

8. Resolution of the Government of the Russian Federation No. 2505 dated December 28, 2021, "On the Program of State Guarantees of Free Medical Care to Citizens for 2022 and for the Planning Period of 2023 and 2024."

9. On the approval of sanitary rules SP 2.1.3678-20 "Sanitary and epidemiological requirements for the operation of premises, buildings, structures, equipment and transport, as well as the conditions of activity of business entities engaged in the sale of goods, performance of work or provision of services" (Resolution of the Chief State Sanitary Doctor of the Russian Federation No. 44 dated December 24, 2020).

10. On the approval of sanitary rules and standards SanPiN 3.3686-21 "Sanitary and epidemiological requirements for the prevention of infectious diseases" (Resolution of the Chief State Sanitary Doctor of the Russian Federation No. 4 dated January 28, 2021).

11. Management of scheduled hospitalization in a multidisciplinary hospital. Methodological recommendations No. 2001/144: (approved by the Ministry of Health of the RF on November 9, 2001).

Table 1. Criteria for selecting management tactics for patients with MH

Appendix B. Physician Action Algorithms

Appendix C. Patient Information