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Not yet recruiting NCT05849974

Large Cohort of 1000 Patients With Severe Myopia

No phase Interventional Myopia, Severe

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Structural and fonctional phynotyping.
Who it may be relevant to
Registry conditions: Myopia, Severe. Basic parameters: from 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • 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

Primary outcome measures

  • Visual acuity [Time frame: 10 years]
  • Refraction measures [Time frame: 10 years]
  • Lens opacity [Time frame: 10 years]
  • Intraocular pressure and pachymetry [Time frame: 10 years]
  • Retinal sensitivity and fixation stability [Time frame: 10 years]
  • Central visual field deficits [Time frame: 10 years]
  • Axial length [Time frame: 10 years]
  • Quantitative data [Time frame: 10 years]
  • qualitative data on OCT : [Time frame: 10 years]
  • Area of Rétinal atrophy [Time frame: 10 years]
Secondary outcome measures (2)
  • Macular ophthalmologic complications [Time frame: 10 years]
  • Non-macular ophthalmologic complications [Time frame: 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05849974 · P22-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗