Back to resultsPupil Dynamics and Color Vision for the Detection of Eye Diseases (PupDyn)
Primary Purpose
Retinitis Pigmentosa, Leber's Hereditary Optic Neuropathy, Stargardt Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dynamic pupillometry sessions
Sponsored by
About this trial
This is an interventional other trial for Retinitis Pigmentosa
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.
Sites / Locations
- Centre Hospitalier National D'Ophtalùmologie des Quinze-Vingts
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dynamic pupillometry sessions
Arm Description
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.
Outcomes
Primary Outcome Measures
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
RAPD measurement
Alternate stimulation of the right and left eye: 10 repetitions, each corresponding to the stimulation of one eye for one second.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04909398
First Posted
May 28, 2021
Last Updated
May 28, 2021
Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Collaborators
Streetlab
1. Study Identification
Unique Protocol Identification Number
NCT04909398
Brief Title
Pupil Dynamics and Color Vision for the Detection of Eye Diseases
Acronym
PupDyn
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 22, 2018 (Actual)
Primary Completion Date
March 22, 2018 (Actual)
Study Completion Date
May 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Collaborators
Streetlab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa, Leber's Hereditary Optic Neuropathy, Stargardt Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dynamic pupillometry sessions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dynamic pupillometry sessions
Intervention Description
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 Outcome Measure Information:
Title
Dynamic pupillometry sessions pupillary reflex measurement
Description
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
Time Frame
Week 1
Title
RAPD measurement
Description
Alternate stimulation of the right and left eye: 10 repetitions, each corresponding to the stimulation of one eye for one second.
Time Frame
Week 1
Title
Endogenous pupillary oscillation measurement
Description
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.
Time Frame
Week 1
Title
Measurement of pupillary activity by frequency marking
Description
This test consists of the simultaneous presentation of 5 areas of the screen, each of which is luminance modulated at a specific frequency.
Time Frame
Week 1
Title
Pupillary measurement of color vision
Description
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.
Time Frame
Week 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saddek MOHAND-SAID
Organizational Affiliation
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier National D'Ophtalùmologie des Quinze-Vingts
City
Paris
ZIP/Postal Code
75012
Country
France
12. IPD Sharing Statement
Learn more about this trial
Pupil Dynamics and Color Vision for the Detection of Eye Diseases
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