Mobility Protocol Adapted for Advanced Visually Impaired Subjects
France50 participantsStarted 2020-03-02
Plain-language summary
Retinitis Pigmentosa is characterized by a progressive disappearance of photoreceptors, responsible for a progressive and severe loss of vision.
People Retinitis Pigmentosa therefore encounter a large number of difficulties in daily life, specifically for:
* Visual research
* Visuo-motor coordination in tasks requiring fine motor control
* Visuo-motor coordination in mobility tasks
This study aims to assess the difficulties in the daily life of subjects with Retinitis Pigmentosa at a very advanced stage unsing, quaify of life questionnaires, simplified locomotion tasks in real situation and a posture task.
They are proposing a new test adapted and carried out in real situations, in binocular and monocular vision, making it possible to finely assess locomotion especially for "very low vision" patients.
This test will also ultimately make it possible to better evaluate the effectivements, that is to say to observe and quantify objectively by a score the performance progression obtained for locomotion tasks related to the visual recovery generated by the treatment.
Who can participate
Age range
18 Years – 75 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:
* Retinitis Pigmentosa, non-syndromic, the diagnosis of which has been confirmed by an ophtmalmologist
* ETDRS visual acuity less than 2/10 (\>+0.7 logMAR; \<20/100 Snellen)
* Doesn't participate in clinical research that may interfere with this study
* Sufficient knowledge of the French language to ensure a perfect understanding of the tasks to be performed and the instructions received
* Consent to the study signed after information by the investigator
* Health insurance affiliation
Exclusion Criteria:
* Pregnant women
* Inability to give personal consent
* Cataract surgery in the 3 months preceding inclusion
* Amblyopia
* Inability to comply with the instructions for carrying out the study tasks or to complete the study visits
* MMSE score without visual item ≤ 20/25
* Drug treatment which can lead to motor, visual or cognitive disorders (PSA, neuroleptics,etc.) or which may interfere with the study's evaluations
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
Discriminating
Timeframe: Month 1
2
Reproducibility
Timeframe: Month 1
3
Validity of construction
Timeframe: Month 1
Trial details
NCT IDNCT04419285
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts