An interventional study of SCL miniaturized scleral lens positioning in Stargardt Disease, sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Not applicable, Interventional, and Supportive care
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.
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.
66 studies on the registry are indexed under Stargardt Disease; 25 are open to participants now.
This study's planned enrollment of 32 is close to the median of 30 across 43 interventional studies indexed under Stargardt Disease.
Browse Stargardt Disease studies →Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts is the lead sponsor of 28 studies on the registry; 16 are open to participants now.
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Patients with Stargardt disease
Healthy volunteers:
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);
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
16 healthy volunteers, sighted controls with visual acuity of at least 10/10th in binocular vision.
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.
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.
Time frame: 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.
Time frame: 45 days
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts