Feasibility and Tolerability Study of Smart Contact Lens With Healthy Subjects and Patients With Stargardt's Disease

Más betegség

• 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;

Laborértékek

• Participants allergic to sodium fluorescein;

Egyéb

• 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.

• 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.