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| Name | Class |
|---|---|
| Ecole Nationale Supérieure Mines - Télécom Atlantique Bretagne Pays de la Loire. | UNKNOWN |
| StreetLab Vision | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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; |
|
| Healthy volunteers | Active Comparator | 16 healthy volunteers, sighted controls with visual acuity of at least 10/10th in binocular vision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCL miniaturized scleral lens positioning | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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);
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Isabelle AUDO, MD | Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | Paris | 75012 | France |
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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.
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|
| ID | Term |
|---|---|
| D000080362 | Stargardt Disease |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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