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Completed

NCT Number: NCT04909398

Pupil Dynamics and Color Vision for the Detection of Eye Diseases

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.

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Leber's Hereditary Optic Neuropathy Macular Degeneration Metabolic Diseases Mitochondrial Diseases Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Optic Atrophies, Hereditary Optic Atrophy Optic Atrophy, Hereditary, Leber Optic Nerve Diseases Retinal Degeneration Retinal Diseases Retinal Dystrophies Stargardt Disease

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier National D'Ophtalùmologie des Quinze-Vingts

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Dynamic pupillometry sessions pupillary reflex measurement

    Time frame: Week 1

    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

  2. RAPD measurement

    Time frame: Week 1

    Alternate stimulation of the right and left eye: 10 repetitions, each corresponding to the stimulation of one eye for one second.

  3. Endogenous pupillary oscillation measurement

    Time frame: Week 1

    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.

  4. Measurement of pupillary activity by frequency marking

    Time frame: Week 1

    This test consists of the simultaneous presentation of 5 areas of the screen, each of which is luminance modulated at a specific frequency.

  5. Pupillary measurement of color vision

    Time frame: Week 1

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Other

Collaborators

  • Streetlab

Registry information

Official study 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

Acronym: PupDyn

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jun 1, 2021
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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