NCT06989658

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Eye tracking is becoming increasingly important in fields such as augmented reality such as augmented reality, virtual reality and healthcare (orthoptic rehabilitation), but is still limited by complex measurement methods that meet user needs. In this context, the proposed research aims to study the feasibility of a system based on a smart contact lens that overcomes several overcome many of the limitations of current oculometers (sensitivity to environmental sensors, size, performance, etc.) and even more so when used by visually impaired people suffering from central vision deficits central vision deficit such as Stargardt's disease. Whether to eccentric fixation or to transmit relevant information about the environment relevant information about their environment, it is necessary to know direction of gaze. Unfortunately, current solutions are not always compatible with the difficulties faced by visually impaired and the SCL system could be a viable and effective solution.

Conditions

• Stargardt Disease

Interventions

Type	Name	Description
DEVICE	SCL miniaturized scleral lens positioning	1. 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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2025-05-25
• Last updated: 2025-09-18

Locations

1 site across 1 country: France