Pupil Dynamics and Color Vision for the Detection of Eye Diseases (NCT04909398) | Clinical Trial Compass
CompletedNot Applicable
Pupil Dynamics and Color Vision for the Detection of Eye Diseases
France60 participantsStarted 2018-03-22
Plain-language summary
The development of new oculometry techniques allows fine and dynamic measurements of pupillary diameter and use in routine clinical practice.
The preliminary results obtained with innovative devices on healthy sjuets make it possible to envisage a clinical study on a population of patients suffering from retinal pathologies.
This is a "proof of concept" study, which, if the expected results are confirmed, will make it possible to consider a study on a larger population, as well as the industrial development of a commercial device.
Who can participate
Age range
18 Years – 60 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 an understanding of the French language to ensure a perfect understanding of the instructions during evaluations and documents relating to their involvement in the study.
Visually impaired volunteers:
Patients must have one of three conditions: Retinitis Pigmentosa, Stargardt disease, Leber optic neuropathy.
Healthy volunteers:
* Visual acuity of both corrected eyes (glasses) should be higher or equal 8/10th and a normal visual field.
* Patients should not wear contact lenses (which may interfere with the recording of the pupil and eye movements)
Exclusion Criteria:
* Pregnant or lactating women will not be able to participate in this research.
* Participants should not be unable to personally consent.
* Subjects should not participate in another clinical trial that may interfere with this research.
* Inability to personally consent.
* Subjects should not present with degenerative diseases or any other disease that could interfere with the evaluations planned during this study.
* The subject follows a drug treatment which can cause visual disturbances, changes in pupillary kinetics or cognitive disturbances.
Secondary exclusion criteria (at the end of the inclusion visit):
* Visually impaired subjects and controls for which calibration is not feasible.
* Patients and control subjects having difficulty maintaining visual fixation.
* Patients and subjects wearing corrective lenses making it impossible to record oculomotor activity w…
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.