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

NCT06989658 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-09-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

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

    collaborator UNKNOWN
  • StreetLab Vision

    collaborator INDUSTRY
  • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

    lead OTHER

Principal Investigators

  • Isabelle AUDO, MD · Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06989658 on ClinicalTrials.gov