Large Cohort of 1000 Patients With Severe Myopia (MyoCo1000)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia, Severe
• Intervention / Treatment: Other: Structural and fonctional phynotyping

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nabil BROUK; Phone Number: +331 40 02 11 26; Email: nbrouk@15-20.fr
• Study Contact Backup: Name: Hayet SERHANE; Phone Number: +331 40 02 11 44; Email: hserhane@15-20.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hight Myopa; Large Cohort of patients with hight Myopa	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular ophthalmologic complications	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	10 years
Non-macular ophthalmologic complications	Glaucoma optic Neuropathy; Cataract; Retinal detachment	10 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Collaborators: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Ramin TADAYONI, Pr, Hôpital Fondation Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): May 1, 2038
• Study Completion (Anticipated): May 1, 2038

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P22-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No