Clinical trial NCT04909398: Pupil Dynamics and Color Vision for the Detection of Eye Diseases
Official title: New Methods of Dynamic Pupillometrics in Subjects With Visual and Color Vision Pathologies for the Detection, Functional Diagnosis and Follow-up of These Pathologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Leber's Hereditary Optic Neuropathy
Stargardt Disease
Lead sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor class: OTHER
Collaborators: name: Streetlab
First posted: 2021-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

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.

Primary outcomes:
measure: Dynamic pupillometry sessions pupillary reflex measurement
timeFrame: Week 1
measure: RAPD measurement
timeFrame: Week 1
measure: Endogenous pupillary oscillation measurement
timeFrame: Week 1
measure: Measurement of pupillary activity by frequency marking
timeFrame: Week 1
measure: Pupillary measurement of color vision
timeFrame: Week 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier National D'Ophtalùmologie des Quinze-Vingts
Study officials:
affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
name: Saddek MOHAND-SAID
role: PRINCIPAL_INVESTIGATOR
References: