Pupil Dynamics and Color Vision for the Detection of Eye Diseases

NCT04909398 | Completed DMC

• 1 other identifier: P17-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Dynamic pupillometry sessions

EXPERIMENTAL

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

Interventions

Dynamic pupillometry sessions 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.

Dynamic pupillometry sessions

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: lead
• Streetlab: collaborator

Study Sites (1)

Centre Hospitalier National D'Ophtalùmologie des Quinze-Vingts

Paris, 75012, France

Location

MeSH Terms

Conditions

Retinitis Pigmentosa; Optic Atrophy, Hereditary, Leber; Stargardt Disease

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Optic Atrophies, Hereditary; Optic Atrophy; Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Mitochondrial Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Macular Degeneration

Study Officials

• Saddek MOHAND-SAID

  Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 1, 2021
• Study Start: March 22, 2018
• Primary Completion: March 22, 2018
• Study Completion: May 22, 2019
• Last Updated: June 1, 2021

Record last verified: 2021-05

Locations

FR (1)