NCT05849974

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
146mo left

Started Jun 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Jun 2023May 2038

First Submitted

Initial submission to the registry

April 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2038

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2038

Last Updated

May 23, 2023

Status Verified

April 1, 2023

Enrollment Period

14.9 years

First QC Date

April 28, 2023

Last Update Submit

May 22, 2023

Conditions

Myopia, Severe

Outcome Measures

Primary Outcomes (14)

  • Visual acuity

    Using the ETDRS and the near vision scale (decimal scales converted to logMAR)

    10 years

  • Refraction measures

    Measure will be performed in diopter

    10 years

  • Lens opacity

    Measure will be performed in pixel units

    10 years

  • Intraocular pressure and pachymetry

    These measurements are respectively carried out in mmHg and in μm

    10 years

  • Retinal sensitivity and fixation stability

    Respectively Performed in decibels and by microperimetry

    10 years

  • Central visual field deficits

    by automatic perimetry in decibels

    10 years

  • Axial length

    Will be performed in mm

    10 years

  • Quantitative data

    On optical coherence tomography (OCT) and OCT-Angiography

    10 years

  • qualitative data on OCT :

    presence of any macular complications: * condition of the posterior vitreous * presence of inner or outer retinal alteration (fluid, layer disorganization, band interruption...).

    10 years

  • Area of Rétinal atrophy

    In autofluorescence (in mm²)

    10 years

  • Characterization of the type of staphyloma

    staphyloma classification

    10 years

  • Vitreous status

    Liquefaction, stage of posterior vitreous detachment

    10 years

  • Excavation of the optic nerve and area

    In mm² of peripapillary atrophy on color and autofluorescence images

    10 years

  • Anterior segment status

    Chamber measurement, corneal curvature (in mm)

    10 years

Secondary Outcomes (2)

  • Macular ophthalmologic complications

    10 years

  • Non-macular ophthalmologic complications

    10 years

Study Arms (1)

Hight Myopa

EXPERIMENTAL

Large Cohort of patients with hight Myopa

Other: Structural and fonctional phynotyping

Interventions

Structural and fonctional phynotypingOTHER

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

Hight Myopa

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Ramin TADAYONI, Pr

    Hôpital Fondation Adolphe de Rothschild

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabil BROUK

CONTACT

+331 40 02 11 26nbrouk@15-20.fr

Hayet SERHANE

CONTACT

+331 40 02 11 44hserhane@15-20.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective, longitudinal, multicentric, non-randomized cohort study with constitution of a biological collection. This study will include major and minor patients with high myopia
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 9, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

May 1, 2038

Study Completion (Estimated)

May 1, 2038

Last Updated

May 23, 2023

Record last verified: 2023-04