Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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