100 High Myopia Patient-reported Outcomes (PRO) and Performance Outcomes (PERFO) (NCT07101146) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
100 High Myopia Patient-reported Outcomes (PRO) and Performance Outcomes (PERFO)
100 participantsStarted 2025-10
Plain-language summary
Prospective, longitudinal, interventional, exploratory, non-randomized, single-center study including patients with pathological myopia .
Who can participate
Age range
18 Years – 55 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:
Patients with pathological myopia and diffuse choroidal atrophy (DCA, Cat. 2 Meta PM)
* Age ≥ 18 years and ≤ 55 years;
* Patient consenting to be included in the study;
* Examination and follow-up in at least one of the participating centers;
* Severe pathological myopia with an axial length ≥ 26.5 mm in both eyes;
* Presence of diffuse atrophy (category 2 of the Meta-PM classification) in the better eye;
* Affiliated with or covered by a social security system.
Pathological myopic patients with patch choroidal atrophy (PCA,
Cat. 3 Meta PM):
* Age ≥ 18 years and ≤ 55 years;
* Patients who consent to be included in the study;
* Examination and follow-up at least one of the participating centers;
* High myopia with an axial length ≥ 26.5 mm in both eyes;
* Presence of patch atrophy (category 3 of the Meta-PM classification) in the better eye;
* Affiliated with or beneficiary of a social security system.
Exclusion Criteria:
* Identified genetic syndromic myopia, including Stickler syndromes type 1 and 2 (collagen 2A1 and 11A1), Marfan syndrome (fibrillin), Ehler-Danlos syndrome type 4 (lysyl-protocollagen hydroxylase), and Knobloch syndrome (collagen 18A).
* Patient unwilling to participate or be followed up at one of the participating centers.
* Binocular visual acuity ≥ 1 logMar (\<0.1 on the decimal scale).
* Media opacities preventing quality imaging, including cataracts.
* Patients benefiting from legal protection measures.
* Pregnant or breastfee…
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
Simulator driving test:Evaluation of pedestrian detection performance using peripheral vision
Timeframe: 2 months
2
Locomotion assessment
Timeframe: 2 months
3
Visual search in VR
Timeframe: 2 months
Trial details
NCT IDNCT07101146
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts