Pupil Dynamics and Color Vision for the Detection of Eye Diseases (PupDyn)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Status: Completed

Conditions: Stargardt Disease; Retinitis Pigmentosa; Leber's Hereditary Optic Neuropathy

Treatments: Behavioral: Dynamic pupillometry sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT04909398

P17-05

Details and patient eligibility

About

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.

Full description

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:

• 15 healthy subjects, called controls.
• 15 patients with retinitis pigmentosa.
• 15 patients with Leber's hereditary optic neuropathy.
• 15 patients with Stargardt's disease.

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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:

• Visual acuity of both corrected eyes (glasses) should be higher or equal 8/10th and a normal visual field.
• Patients should not wear contact lenses (which may interfere with the recording of the pupil and eye movements)

Exclusion criteria

• Pregnant or lactating women will not be able to participate in this research.
• Participants should not be unable to personally consent.
• Subjects should not participate in another clinical trial that may interfere with this research.
• Inability to personally consent.
• Subjects should not present with degenerative diseases or any other disease that could interfere with the evaluations planned during this study.
• The subject follows a drug treatment which can cause visual disturbances, changes in pupillary kinetics or cognitive disturbances.

Secondary exclusion criteria (at the end of the inclusion visit):

• Visually impaired subjects and controls for which calibration is not feasible.
• Patients and control subjects having difficulty maintaining visual fixation.
• Patients and subjects wearing corrective lenses making it impossible to record oculomotor activity with an infrared camera oculometer.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Dynamic pupillometry sessions

Experimental group

Description:

It is planned to include 60 participants divided into different groups: * 15 healthy subjects, called controls. * 15 patients with retinitis pigmentosa. * 15 patients with Leber's hereditary optic neuropathy. * 15 patients with Stargardt's disease.

Treatment:

Behavioral: Dynamic pupillometry sessions