NCT06949579 Risk of Posterior Staphyloma in Highly Myopic Europeans : From Epidemiology to Anatomy.
| NCT ID | NCT06949579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | High Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-02-02 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this cross-sectionnal study the aim is to increase the understanding of posterior staphyloma through a unique European consortium. Therefore, all eligible patients that either visit the outpatient clinic at Radboud in Nimegen, the Netherlands, or visit University Hopital Puerta de HierroMajadahonda in Madrid, Spain, or visit University Hospital Cochin in Paris, France, and after consenting, will be included. 600 high myopic European cases are expecting. A standardized protocol in all centers in order to create a uniform dataset. Besides the standard of care, blood samples will be collected. All data collected will be stored in an onlie Castor database
Eligibility Criteria
Inclusion Criteria: * Adults with high myopia (axial length ≥ 26.00 mm or degree of myopia of at least -6 diopters), with and without posterior staphyloma * Adults aged 18 years or over * Patient with high myopia (axial length ≥ 26.00 mm or degree of myopia of at least -6 diopters), with good quality retinal imaging * Patient who has signed a consent form to participate in the study * Patient who is a beneficiary of a social security scheme or who is entitled to it Exclusion Criteria: * Any systemic or ocular pathologies with an impact on the posterior segment of the eye * Patient with a systemic pathology likely to affect the posterior segment of the eye: * Diabetes * Systemic inflammatory disease: sarcoidosis, rheumatoid arthritis, systemic lupus erythematosus, Horton's disease * Patients with retinitis pigmentosa * Patients with syndromic myopia * Patients with myopia associated with a genetic disease such as hereditary vitreoretinopathy * Patients under guardianship, curatorship or legal protection, as well as pregnant or breastfeeding women (article L1121-5 of the CSP).
Contact & Investigator
Francine BEHAR-COHEN, MD,PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06949579 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying High Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06949579 currently recruiting?
Yes, NCT06949579 is actively recruiting participants. Contact the research team at francine.cohen@aphp.fr for enrollment information.
Where is the NCT06949579 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06949579 clinical trial?
NCT06949579 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Francine BEHAR-COHEN, MD,PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 200 participants.