MyoCo1000: Large Cohort of 1000 Patients With Severe Myopia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hight Myopa Large Cohort of patients with hight Myopa |
Other: Structural 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
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Outcome Measures
Primary Outcome Measures
- 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
- 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
- Anterior segment status [10 years]
Chamber measurement, corneal curvature (in mm)
Secondary Outcome Measures
- 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
- Non-macular ophthalmologic complications [10 years]
Glaucoma optic Neuropathy Cataract Retinal detachment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 6 years
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Severe myopia in at least one eye, defined as
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a refractive error ≤ -6.00 diopters OR
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an axial length ≥ 26.50 mm
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Follow-up performed at at least one of the participating centers
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Express consent to participate in the study
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If age < 18 years: express consent of the person(s) exercising parental authority
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Affiliated or beneficiary of a health insurance
Exclusion Criteria:
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Visual acuity < 5 letters on the ETDRS (equivalent to "finger count" or less) in both eyes
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Disorders of the transparent media in both eyes with opacities that may affect image quality
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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)
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Patient who does not wish to continue to be followed in one of the participating centers
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Patient benefiting from a legal protection measure
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Pregnant or breastfeeding woman
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Fondation Ophtalmologique Adolphe de Rothschild
Investigators
- Principal Investigator: Ramin TADAYONI, Pr, Hôpital Fondation Adolphe de Rothschild
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P22-03