NCT04909398

Pupil Dynamics and Color Vision for the Detection of Eye Diseases

New Methods of Dynamic Pupillometrics in Subjects With Visual and Color Vision Pathologies for the Detection, Functional Diagnosis and Follow-up of These Pathologies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Retinitis Pigmentosa
• Leber's Hereditary Optic Neuropathy
• Stargardt Disease

Interventions

Type	Name	Description
BEHAVIORAL	Dynamic pupillometry sessions	The evaluation protocol will include the following steps: * Installation of the subject, adaptation of the chin rest for the best comfort of the participant * Calibration of the oculometer consisting of ocular fixation of 9 fixation points distributed on the stimulation screen * Final validation of the eligibility of the subject in the study according to the success or not of the calibration.

Timeline

• Start date: 2018-03-22
• Primary completion: 2018-03-22
• Completion: 2019-05-22
• First posted: 2021-06-01
• Last updated: 2021-06-01

Locations

1 site across 1 country: France