Clinical trial NCT05849974: Large Cohort of 1000 Patients With Severe Myopia
Official title: Large Cohort of 1000 Patients With Severe Myopia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myopia, Severe
Lead sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor class: OTHER
Collaborators: name: Fondation Ophtalmologique Adolphe de Rothschild
First posted: 2023-05-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Visual acuity
timeFrame: 10 years
measure: Refraction measures
timeFrame: 10 years
measure: Lens opacity
timeFrame: 10 years
measure: Intraocular pressure and pachymetry
timeFrame: 10 years
measure: Retinal sensitivity and fixation stability
timeFrame: 10 years
measure: Central visual field deficits
timeFrame: 10 years
measure: Axial length
timeFrame: 10 years
measure: Quantitative data
timeFrame: 10 years
measure: qualitative data on OCT :
timeFrame: 10 years
measure: Area of Rétinal atrophy
timeFrame: 10 years
measure: Characterization of the type of staphyloma
timeFrame: 10 years
measure: Vitreous status
timeFrame: 10 years
measure: Excavation of the optic nerve and area
timeFrame: 10 years
measure: Anterior segment status
timeFrame: 10 years
Secondary outcomes:
measure: Macular ophthalmologic complications
timeFrame: 10 years
measure: Non-macular ophthalmologic complications
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Fondation Adolphe de Rothschild
name: Ramin TADAYONI, Pr
role: PRINCIPAL_INVESTIGATOR
References: