Feasibility and Tolerability Study of Smart Contact Lens With Healthy Subjects and Patients With … (NCT06989658) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility and Tolerability Study of Smart Contact Lens With Healthy Subjects and Patients With Stargardt's Disease
France32 participantsStarted 2025-10
Plain-language 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 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
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 Criteria:
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: g…
What they're measuring
1
Occurrence rate of adverse events, unexpected adverse events or serious adverse events
Timeframe: 45 days
2
Ergonomics evaluation
Timeframe: 45 days
Trial details
NCT IDNCT06989658
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts