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| Name | Class |
|---|---|
| Streetlab | INDUSTRY |
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The development of new oculometry techniques allows fine and dynamic measurements of pupillary diameter and use in routine clinical practice.
The preliminary results obtained with innovative devices on healthy sjuets make it possible to envisage a clinical study on a population of patients suffering from retinal pathologies.
This is a "proof of concept" study, which, if the expected results are confirmed, will make it possible to consider a study on a larger population, as well as the industrial development of a commercial device.
This is a single-head study that will take place at the National Ophthalmology Hospital Center (CHNO) and the Vision Institute (Streetlab) and the total duration of the study is 24 months .
It is planned to include 60 participants divided into different groups:
Patients will be pre-selected on files at the CHNO clinical investigation center based on the visual assessment carried out on the day of their arrival, the doctor may suggest that they participate in the study if the inclusion criteria are respected.
The control subjects will be recruited thanks to the database of the Vision Institute at Streetlab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic pupillometry sessions | Experimental | It is planned to include 60 participants divided into different groups:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic pupillometry sessions | Behavioral | The evaluation protocol will include the following steps:
|
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic pupillometry sessions pupillary reflex measurement | Measurement of the right eye / left eye and binocular monocular pupillary reflex: pupillary response measured for 5 seconds with 3 levels of screen luminance, each stimulation will be separated from the next by a delay of 5 seconds | Week 1 |
| RAPD measurement | Alternate stimulation of the right and left eye: 10 repetitions, each corresponding to the stimulation of one eye for one second. | Week 1 |
| Endogenous pupillary oscillation measurement | Pupil oscillation frequency, for each eye and in binocular: during this test the participants observe the stimulation screen (central fixation point) for 45 seconds during which the lumnance of the screen is calculated to be proportional to the size of the pupil in real time. | Week 1 |
| Measurement of pupillary activity by frequency marking | This test consists of the simultaneous presentation of 5 areas of the screen, each of which is luminance modulated at a specific frequency. | Week 1 |
| Pupillary measurement of color vision | In this test, 2 background colors alternate at low frequency over time. The physical luminance of one color is fixed while the other is adaptively changed during a test to reduce pupillary response. | Week 1 |
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Inclusion Criteria:
- Patients with an understanding of the French language to ensure a perfect understanding of the instructions during evaluations and documents relating to their involvement in the study.
Visually impaired volunteers:
Patients must have one of three conditions: Retinitis Pigmentosa, Stargardt disease, Leber optic neuropathy.
Healthy volunteers:
Exclusion Criteria:
Secondary exclusion criteria (at the end of the inclusion visit):
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| Name | Affiliation | Role |
|---|---|---|
| Saddek MOHAND-SAID | Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier National D'Ophtalùmologie des Quinze-Vingts | Paris | 75012 | France |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D029242 | Optic Atrophy, Hereditary, Leber |
| D000080362 | Stargardt Disease |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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|
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015418 | Optic Atrophies, Hereditary |
| D009896 | Optic Atrophy |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D028361 | Mitochondrial Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008268 | Macular Degeneration |