Status:
NOT_YET_RECRUITING
Feasibility and Tolerability Study of Smart Contact Lens With Healthy Subjects and Patients With Stargardt's Disease
Lead Sponsor:
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Collaborating Sponsors:
Ecole Nationale Supérieure Mines - Télécom Atlantique Bretagne Pays de la Loire.
StreetLab Vision
Conditions:
Stargardt Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Oculometry is becoming increasingly popular in fields such as enhanced reality and healthcare, but remains limited by complex devices that are poorly adapted to the needs of users, particularly the vi...
Detailed Description
Eye tracking is becoming increasingly important in fields such as augmented reality such as augmented reality, virtual reality and healthcare (orthoptic rehabilitation), but is still limited by comple...
Eligibility Criteria
Inclusion
- Patients with Stargardt disease
- Age: 18 - 70 ;
- Juvenile form of Stargardt's disease manifested by decreased visual acuity;
- Visual acuity greater than or equal to 20/400 in binocular vision;
- MMSE score without visual item ≥ 20/25 ;
- Eyes whose palpebral opening and ocular surface and its appendages allow the wearing of a scleral lens;
- Sufficient knowledge of the French language.
- Ability to give express, free and informed consent in person, after having received adequate information;
- Ability to comply with protocol requirements;
- Person covered by Health Insurance.
- Healthy volunteers:
- Age: 18 - 70 years;
- Age- and sex-matched healthy volunteers to subjects with Stargardt's disease (± 5 years);
- MMSE score with visual items ≥ 25/30 ;
- Eyes with palpebral opening and ocular surface and appendages suitable for scleral lens wear;
- Visual acuity of at least 10/10 in binocular vision;
- Sufficient knowledge of the French language;
- Ability to give personal, express, written, free and informed consent after receiving adequate information ;
- Ability to comply with protocol requirements;
- Person covered by Health Insurance.
Exclusion
- For all participantsPersons referred to in articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons : pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or curatorship);
- Participants with neurodegenerative diseases or any other disease that could interfere with the planned evaluations during this study;
- Participants with ophthalmological diseases other than Stargardt's disease;
- Participants with a history of cleft palate, corneal infection, irregular cornea (such as keratoconus) and severe dry eye syndrome as determined by the ophthalmologist;
- Participants allergic or sensitive to methyl acrylic poly methacrylate (PMMA) or to any of the components of the Re-See lens;
- Participants allergic to tropicamide, atropine or its derivatives
- Participants at risk of angle-closure glaucoma;
- Participants allergic to sodium fluorescein;
- Suspicion of transmissible spongiform encephalopathy;
- Medications that may cause motor, visual or cognitive disorders (neuroleptics, etc.) or that may interfere with study evaluations;
- Participation in another clinical trial that could interfere with the present study;
- Inability to follow instructions or read. ☞Wearing glasses or contact lenses is not a non inclusion criterion.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06989658
Start Date
October 1 2025
End Date
February 1 2028
Last Update
September 18 2025
Active Locations (1)
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1
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, France, 75012