Myopia, Severe
Conditions
Brief summary
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
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
Interventions
OTHERStructural and fonctional phynotyping
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
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior segment status | 10 years | Chamber measurement, corneal curvature (in mm) |
| Vitreous status | 10 years | Liquefaction, stage of posterior vitreous detachment |
| Excavation of the optic nerve and area | 10 years | In mm² of peripapillary atrophy on color and autofluorescence images |
| Visual acuity | 10 years | Using the ETDRS and the near vision scale (decimal scales converted to logMAR) |
| Refraction measures | 10 years | Measure will be performed in diopter |
| Lens opacity | 10 years | Measure will be performed in pixel units |
| Intraocular pressure and pachymetry | 10 years | These measurements are respectively carried out in mmHg and in μm |
| Retinal sensitivity and fixation stability | 10 years | Respectively Performed in decibels and by microperimetry |
| Central visual field deficits | 10 years | by automatic perimetry in decibels |
| Axial length | 10 years | Will be performed in mm |
| Quantitative data | 10 years | On optical coherence tomography (OCT) and OCT-Angiography |
| qualitative data on OCT : | 10 years | presence of any macular complications: * condition of the posterior vitreous * presence of inner or outer retinal alteration (fluid, layer disorganization, band interruption...). |
| Area of Rétinal atrophy | 10 years | In autofluorescence (in mm²) |
| Characterization of the type of staphyloma | 10 years | staphyloma classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-macular ophthalmologic complications | 10 years | * Glaucoma optic Neuropathy * Cataract * Retinal detachment |
| Macular ophthalmologic complications | 10 years | 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 |
Contacts
Primary ContactNabil BROUK
Backup ContactHayet SERHANE
Outcome results
None listed