Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06949579

Risk of Posterior Staphyloma in Highly Myopic Europeans: From Epidemiology to Anatomy

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-31

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

U

URC-CIC Paris Descartes Necker Cochin

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating posterior staphyloma, a condition affecting the eyes of people with high myopia, within a European population across three countries. The study aims to understand the genetic, biological, and anatomical characteristics of myopic staphyloma by comparing patients with and without this condition. A genome-wide association study (GWAS) will help identify genetic variations linked to posterior staphyloma in 600 highly myopic European participants. Participants will be divided into two groups: 300 with posterior staphyloma and 300 without. Blood samples will be collected for DNA, serum, and plasma analysis, and peripheral blood mononuclear cells (PBMCs) will be used to create induced pluripotent stem cells (iPSCs) for further laboratory study. The study will use standardized protocols across centers in the Netherlands, Spain, and France to ensure consistent data collection. During the study, participants will receive standard eye care and undergo retinal imaging to assess eye structure and complications. Researchers will analyze genetic markers, protein biomarkers, and cellular responses, correlating these with clinical features such as visual acuity and anatomical changes. Data will be securely stored, and the study is expected to last about one year, with additional follow-up to compare findings among countries.

CONDITIONS

Brief Title

Risk of Posterior Staphyloma in Highly Myopic Europeans : From Epidemiology to Anatomy.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of high myopia with axial length 26.00 mm or more or myopia degree of at least -6 diopters
  • Good quality retinal imaging available
  • Signed informed consent to participate
  • Beneficiary of or entitled to a social security scheme
Not Eligible

You will not qualify if you...

  • Presence of any systemic disease affecting the back of the eye including diabetes, sarcoidosis, rheumatoid arthritis, systemic lupus erythematosus, or Horton's disease
  • Diagnosis of retinitis pigmentosa
  • Syndromic myopia or myopia linked to genetic diseases such as hereditary vitreoretinopathy
  • Individuals under legal guardianship, curatorship, or legal protection
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Blood Sampling and Imaging Assessment

Duration - Up to 25 months

Participants undergo blood sampling for DNA, serum, plasma, and peripheral blood mononuclear cells collection. Retinal imaging and clinical assessments are performed to characterize the phenotype of high myopia with or without posterior staphyloma.

1 to 2 visits depending on assessments

Long-term Monitoring

Duration - Approximately 1 year

Participants are followed for up to 1 year to monitor gene expression differences and correlations between phenotype and systemic molecular markers.

Follow-up visits as needed over 1 year

Trial Site Locations

Total: 1 location

1

Cochin Hospital

Paris, France, 75014

Actively Recruiting

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Research Team

F

Francine Behar-Cohen, MD, PhD

V

Valérie PLENCE, Msc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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