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

NCT ID: NCT06989658

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2028-02-29

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient with Stargardt disease

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

Group Type: EXPERIMENTAL

SCL miniaturized scleral lens positioning

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

SCL miniaturized scleral lens positioning

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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;
• Visual acuity of at least 10/10 in binocular vision;
• Sufficient knowledge of the French language;
• Ability to give personal, express, written, free and informed consent after receiving adequate information ;
• Ability to comply with protocol requirements;
• Person covered by Health Insurance.

Exclusion Criteria

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;
• Inability to follow instructions or read. ☞Wearing glasses or contact lenses is not a non inclusion criterion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

StreetLab Vision

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle AUDO, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Locations

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, , France

Countries

France

Central Contacts

Isabelle AUDO, Pr

Role: CONTACT

Isabelle.audo@inserm.fr

00 33 1 40 02 14 30

Dorothée Dagostinoz

Role: CONTACT

ddagostinoz@15-20.fr

00 33 1 40 02 14 57

Facility Contacts

Isabelle AUDO, PU-PH

Role: primary

isabelle.audo@inserm.fr

00 33 1 40 02 14 30

Dorothée Dagostinoz

Role: backup

ddagostinoz@15-20.fr

00 33 1 40 02 14 57

Other Identifiers

P23-01

Identifier Type: -

Identifier Source: org_study_id