Risk of Posterior Staphyloma in Highly Myopic Europeans : From Epidemiology to Anatomy. (NCT06949579) | Clinical Trial Compass
RecruitingNot Applicable
Risk of Posterior Staphyloma in Highly Myopic Europeans : From Epidemiology to Anatomy.
France200 participantsStarted 2026-02-02
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differential gene expression between myopic patients with and without staphyloma
Timeframe: Through study completion, an average of 1 year.