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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts

About this trial

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.

Eligibility criteria

Qualifiers

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 ;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • SCL miniaturized scleral lens positioning

Treatment groups

32 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Lead sponsor

Ecole Nationale Supérieure Mines - Télécom Atlantique Bretagne Pays de la Loire.

Collaborator

StreetLab Vision

Collaborator