Stargardt DiseaseRE-SEENCT06989658
Feasibility and Tolerability Study of Smart Contact Lens With Healthy Subjects and Patients With Stargardt's Disease
A study testing SCL miniaturized scleral lens positioning in people with Stargardt Disease, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stargardt Disease
- What is being tested?
- SCL miniaturized scleral lens positioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012
Isabelle AUDO, PU-PH, 00 33 1 40 02 14 30, isabelle.audo@inserm.fr
Dorothée Dagostinoz, 00 33 1 40 02 14 57, ddagostinoz@15-20.fr
About this study
Official title: Feasibility and Tolerability Study of Wearing a Miniaturized Smart Contact Lens With Healthy Subjects and Patients With Stargardt's Disease
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.
Read the 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
- Being tested
- SCL miniaturized scleral lens positioning
- Medical subject headings
- Stargardt Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCL miniaturized scleral lens positioningDevice
- Experimental evaluation:
- TESTs withSCL system
- Before positioning the SCL lens: slit lamp examination
- After positioning the SCL lens: slit-lamp examination
- Tests performed on projected screen.
- Tests with a conventional oculometer: tests performed on a projected screen.
- Ophthalmological assessment:
- slit lamp examination
- An end-of-study follow-up phone call.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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. Receives: Device: SCL miniaturized scleral lens positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study startOct 2025 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stargardt DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Nationale Supérieure Mines - Télécom Atlantique Bretagne Pays de la Loire., StreetLab Vision
- Responsible party
- Sponsor
- Investigators
- Isabelle AUDO, MD, Principal investigator, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989658
- Sponsor's protocol ID
- P23-01
- Acronym
- RE-SEE
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Tolerability Study of Wearing a Miniaturized Smart Contact Lens With Healthy Subjects and Patients With Stargardt's Disease
- ClinicalTrials.gov ID
- NCT06989658
- Acronym / sponsor ID
- RE-SEE / P23-01
- Conditions
- Stargardt Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Collaborators
- Ecole Nationale Supérieure Mines - Télécom Atlantique Bretagne Pays de la Loire., StreetLab Vision
- Study start
- Oct 2025 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patient with Stargardt disease | Experimental | Device: SCL miniaturized scleral lens positioning16 patients with Stargardt's disease, whose visual acuity will be greater than or equal to 20/400e in binocular vision; |
| Healthy volunteers | Active comparator | Device: SCL miniaturized scleral lens positioning16 healthy volunteers, sighted controls with visual acuity of at least 10/10th in binocular vision. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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 ;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCL miniaturized scleral lens positioning1. 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. | Device | Healthy volunteers, Patient with Stargardt disease |
Primary outcome
Occurrence rate of adverse events, unexpected adverse events or serious adverse events
Time frame: 45 days
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
Time frame: 45 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle AUDO, MD principal investigator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCL miniaturized scleral lens positioning in people with Stargardt Disease, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle AUDO, Pr (00 33 1 40 02 14 30, Isabelle.audo@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence rate of adverse events, unexpected adverse events or serious adverse events (time frame: 45 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.