Large Cohort of 1000 Patients With Severe Myopia

Not Applicable

Not yet recruiting

• Conditions: Myopia, Severe
• Interventions: Other: Structural and fonctional phynotyping

• Registration Number: NCT05849974
• Lead Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

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

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-09
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-23
• Study Start: 2023-06
• Primary Completion: 2038-05
• Study Completion: 2038-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hight Myopa	Structural and fonctional phynotyping	Large Cohort of patients with hight Myopa

Primary Outcome Measures

Name	Time	Method
Axial length	10 years	Will be performed in mm
Retinal sensitivity and fixation stability	10 years	Respectively Performed in decibels and by microperimetry
Area of Rétinal atrophy	10 years	In autofluorescence (in mm²)
Characterization of the type of staphyloma	10 years	staphyloma classification
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...).
Anterior segment status	10 years	Chamber measurement, corneal curvature (in mm)
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
Excavation of the optic nerve and area	10 years	In mm² of peripapillary atrophy on color and autofluorescence images
Intraocular pressure and pachymetry	10 years	These measurements are respectively carried out in mmHg and in μm
Central visual field deficits	10 years	by automatic perimetry in decibels
Quantitative data	10 years	On optical coherence tomography (OCT) and OCT-Angiography
Vitreous status	10 years	Liquefaction, stage of posterior vitreous detachment
Lens opacity	10 years	Measure will be performed in pixel units

Secondary Outcome Measures

Name	Time	Method
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