Pupil Dynamics and Color Vision for the Detection of Eye Diseases

NCT ID: NCT04909398

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-22
• Study Completion Date: 2019-05-22

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dynamic pupillometry sessions

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.

Group Type: EXPERIMENTAL

Dynamic pupillometry sessions

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Streetlab

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saddek MOHAND-SAID

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Locations

Centre Hospitalier National D'Ophtalùmologie des Quinze-Vingts

Paris, , France

Countries

France

Other Identifiers

P17-05

Identifier Type: -

Identifier Source: org_study_id