Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT06989658
Eligibility Criteria:
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: 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06989658
Study Brief:
Protocol Section:
NCT06989658