Large Cohort of 1000 Patients With Severe Myopia

NCT ID: NCT05849974

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2038-05-31

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

Conditions

Myopia, Severe

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Hight Myopa

Large Cohort of patients with hight Myopa

Group Type: EXPERIMENTAL

Structural and fonctional phynotyping

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: collaborator

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramin TADAYONI, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Fondation Adolphe de Rothschild

Central Contacts

Nabil BROUK

Role: CONTACT

nbrouk@15-20.fr

+331 40 02 11 26

Hayet SERHANE

Role: CONTACT

hserhane@15-20.fr

+331 40 02 11 44

Other Identifiers

P22-03

Identifier Type: -

Identifier Source: org_study_id