NCT06989658Not yet recruiting
Feasibility and Tolerability Study of Smart Contact Lens With Healthy Subjects and Patients With Stargardt's Disease
Feasibility and Tolerability Study of Wearing a Miniaturized Smart Contact Lens With Healthy Subjects and Patients With Stargardt's Disease
Source: ClinicalTrials.gov · Last updated 18 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 visually impaired. This research proposes to explore a smart contact lens (SCL)-based system to overcome these limitations, particularly for people with central visual deficits such as Stargardt's disease.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 6 May 2025
- Start date
- Oct 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- NCT number
- NCT06989658
What you commit to
- Study type: Interventional
- Planned participants: 32
- From Oct 2025 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Medications that may cause motor, visual or cognitive disorders (neuroleptics, etc.) or that may interfere with study evaluations;
Lab values
- Participants allergic to sodium fluorescein;
Other
- 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 at risk of angle-closure glaucoma;
- Suspicion of transmissible spongiform encephalopathy;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier National D'ophtalmologie Des Quinze Vingts Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.