oCular Examination at Cell RESolution With Optical TransmissionTomography (NCT06976034) | Clinical Trial Compass
RecruitingNot Applicable
oCular Examination at Cell RESolution With Optical TransmissionTomography
France300 participantsStarted 2024-11-12
Plain-language summary
Understanding the pathogenesis of eye diseases has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems, such as optical coherence tomography (OCT), are limited in terms of resolution, acquisition speed or access to certain eye functions. Our team has participated in the development of a new generation of imaging technology known as optical transmission tomography (OTT), which enables imaging of the anterior parts of the eye with high cellular resolution, a wide field of view and reduced examination delay.
Who can participate
Age range
18 Years – 80 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:
For Patients:
* 200 subjects aged 18 to 80 years;
* Male or female;
* with an ocular disease affecting the cornea, ocular surface, lens (cataract) or glaucoma, or requiring refractive surgery or post-refractive surgery follow-up;
* Are covered by the French Assurance Maladie;
* Have signed an express, free and informed consent form.
For Healthy volunteers:
* 100 subjects aged 18 to 80 years;
* Male or female;
* Healthy subjects with no known pathology directly or indirectly affecting ocular structures;
* Covered by the French Assurance Maladie.
* Having signed an express, free and informed consent form.
Exclusion Criteria:
For all participants:
* Inability to hold a still position on a standard ophthalmic chin rest;
* Conjunctivitis or other contagious contact disease in active phase;
* Having an implanted pacemaker or other electronic medical device;
* Having a predisposition to iridocorneal angle closure;
* Vulnerable persons or persons under legal protection (pregnant or breast-feeding women; persons under guardianship,
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
Image quality
Timeframe: between 1 day and 4 years
2
Endothelial cell density
Timeframe: between 1 day and 4 years
3
Imaging new corneal and lens structures
Timeframe: between 1 day and 4 years
Trial details
NCT IDNCT06976034
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts