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.
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 ;
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;
Sequential
SCL miniaturized scleral lens positioning
Device1. Experimental evaluation: 1. TESTs withSCL system * Before positioning the SCL lens: slit lamp examination * After positioning the SCL lens: slit-lamp examination * Tests performed on projected screen. 2. Tests with a conventional oculometer: tests performed on a projected screen. 2. Ophthalmological assessment: 1. slit lamp examination 2. An end-of-study follow-up phone call.
Occurrence rate of adverse events, unexpected adverse events or serious adverse events
Ophthalmological consultation (including slit-lamp corneal examination) and subject interrogation. Each reported event will be analyzed to monitor its evolution (resolution or not, necessary treatments...) and to estimate the imputation with the wearing of the LCS lens.
Ergonomics evaluation
To evaluate the ergonomics: comfort, acceptability and usefulness of the SCL lens with subjects suffering from central vision deficit (Stargardt's disease) and healthy control subjects, we will use the satisfaction questionnaire we have specially designed. Analysis of the results of the close-ended and semi-open-ended questions will enable us to answer this question.
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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
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