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

NCT06989658 | Not Yet Recruiting DMC

• 1 other identifier: P23-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Stargardt Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  45 days

• 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.

  45 days

Study Arms (2)

Patient with Stargardt disease

EXPERIMENTAL

16 patients with Stargardt's disease, whose visual acuity will be greater than or equal to 20/400e in binocular vision;

Device: SCL miniaturized scleral lens positioning

Healthy volunteers

ACTIVE COMPARATOR

16 healthy volunteers, sighted controls with visual acuity of at least 10/10th in binocular vision.

Device: SCL miniaturized scleral lens positioning

Interventions

SCL miniaturized scleral lens positioning DEVICE

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.

Healthy volunteers; Patient with Stargardt disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: lead
• Ecole Nationale Supérieure Mines - Télécom Atlantique Bretagne Pays de la Loire.: collaborator
• StreetLab Vision: collaborator

Study Sites (1)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, 75012, France

Location

MeSH Terms

Conditions

Stargardt Disease

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Isabelle AUDO, MD

  Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle AUDO, Pr

CONTACT

00 33 1 40 02 14 30; Isabelle.audo@inserm.fr

Dorothée Dagostinoz

CONTACT

00 33 1 40 02 14 57; ddagostinoz@15-20.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We have made the methodological choice of including healthy volunteers first, in order to validate the feasibility and tolerance of the SCL lens in people with healthy eyes. If no serious adverse events occur in the first 12 control subjects, we will then be able to begin enrolling patients with Stargardt's disease.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 25, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-05

Locations

FR (1)