Large Cohort of 1000 Patients With Severe Myopia

Study Overview
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Brief Summary
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The prevalence of myopia and severe myopia are increasing and will affect 50% and 10% of the population respectively. Severe myopia exposes an increased risk of glaucoma, cataract, retinal detachment and myopic maculopathy, a source of visual impairment. To date, no European cohort study has been conducted to estimate the rate of these complications and to study the predictive parameters.

Detailed Description
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This study allows to describe the evolution of different ophthalmological parameters of a population of strong myopes during their follow-up for 10 years using multimodal imaging techniques of the retina. Prospective, longitudinal, multicentric, non-randomized cohort study with constitution of a biological collection. This study will include major and minor patients with high myopia

Official Title
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Large Cohort of 1000 Patients With Severe Myopia

Conditions
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Myopia, Severe

Intervention / Treatment
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* Other: Structural and fonctional phynotyping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 6 years Severe myopia in at least one eye, defined as a refractive error ≤ -6.00 diopters OR an axial length ≥ 26.50 mm Follow-up performed at at least one of the participating centers Express consent to participate in the study If age < 18 years: express consent of the person(s) exercising parental authority Affiliated or beneficiary of a health insurance Exclusion Criteria: Visual acuity < 5 letters on the ETDRS (equivalent to finger count or less) in both eyes Disorders of the transparent media in both eyes with opacities that may affect image quality Syndromic myopia of genetic origin (Stickler syndrome type 1 and 2, Marfan syndrome, Ehler-Danlos disease type 4, Knobloch syndrome) or inherited retinal dystrophy (X-linked retinitis pigmentosa, congenital stationary night blindness of Schubert-Bornshein type, Bornholm eye disease) Patient who does not wish to continue to be followed in one of the participating centers Patient benefiting from a legal protection measure Pregnant or breastfeeding woman

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, longitudinal, multicentric, non-randomized cohort study with constitution of a biological collection. This study will include major and minor patients with high myopia
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hight Myopa<br>Large Cohort of patients with hight Myopa | Other: Structural and fonctional phynotyping<br>* The additioan acts in this research are: Fonctionnal phenotyping:Retinal sensitivity and fixation stability assessment using microperimetry, assessment of long-term fixation stability Structural Phenotyping: Anterior segment examination with OCT anterior Blood sample collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Using the ETDRS and the near vision scale (decimal scales converted to logMAR) | 10 years | 
| Refraction measures | Measure will be performed in diopter | 10 years | 
| Lens opacity | Measure will be performed in pixel units | 10 years | 
| Intraocular pressure and pachymetry | These measurements are respectively carried out in mmHg and in μm | 10 years | 
| Retinal sensitivity and fixation stability | Respectively Performed in decibels and by microperimetry | 10 years | 
| Central visual field deficits | by automatic perimetry in decibels | 10 years | 
| Axial length | Will be performed in mm | 10 years | 
| Quantitative data | On optical coherence tomography (OCT) and OCT-Angiography | 10 years | 
| qualitative data on OCT : | presence of any macular complications: condition of the posterior vitreous presence of inner or outer retinal alteration (fluid, layer disorganization, band interruption...). | 10 years | 
| Area of Rétinal atrophy | In autofluorescence (in mm²) | 10 years | 
| Characterization of the type of staphyloma | staphyloma classification | 10 years | 
| Vitreous status | Liquefaction, stage of posterior vitreous detachment | 10 years | 
| Excavation of the optic nerve and area | In mm² of peripapillary atrophy on color and autofluorescence images | 10 years | 
| Anterior segment status | Chamber measurement, corneal curvature (in mm) | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular ophthalmologic complications | Diffuse atrophy/patch atrophy/macular atrophy Choroidal neovessel Bruch's membrane rupture Bulging macula Papillary dysversion Myopic staphyloma Epiretinal membrane Lamellar hole Myopic foveoschisis Macular hole | 10 years | 
| Non-macular ophthalmologic complications | Glaucoma optic Neuropathy Cataract Retinal detachment | 10 years |