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

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

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.

Study Overview

• Status: Completed
• Conditions: Retinitis Pigmentosa; Leber's Hereditary Optic Neuropathy; Stargardt Disease
• Intervention / Treatment: Behavioral: Dynamic pupillometry sessions

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Centre Hospitalier National D'Ophtalùmologie des Quinze-Vingts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Collaborators: Streetlab
• Investigators: Principal Investigator: Saddek MOHAND-SAID, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2018
• Primary Completion (ACTUAL): March 22, 2018
• Study Completion (ACTUAL): May 22, 2019

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (ACTUAL): June 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Neurodegenerative Diseases; Eye Diseases, Hereditary; Retinal Dystrophies; Heredodegenerative Disorders, Nervous System; Macular Degeneration; Cranial Nerve Diseases; Optic Atrophies, Hereditary; Optic Atrophy; Mitochondrial Diseases; Retinitis; Retinitis Pigmentosa; Optic Nerve Diseases; Optic Atrophy, Hereditary, Leber; Stargardt Disease
• Other Study ID Numbers: P17-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No