Retinitis PigmentosaPupDynNCT04909398
Pupil Dynamics and Color Vision for the Detection of Eye Diseases
A study testing Dynamic pupillometry sessions in people with Retinitis Pigmentosa and Leber's Hereditary Optic Neuropathy, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinitis Pigmentosa, Leber's Hereditary Optic Neuropathy, Stargardt Disease
- What is being tested?
- Dynamic pupillometry sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2018to 22 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier National D'Ophtalùmologie des Quinze-Vingts
Paris, 75012
About this study
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
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.
Read the 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.
- Being tested
- Dynamic pupillometry sessions
- Medical subject headings
- Retinitis Pigmentosa, Optic Atrophy, Hereditary, Leber, Stargardt Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic pupillometry sessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Dynamic pupillometry sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start22 Mar 2018
- Primary completion22 Mar 2018
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Collaborators
- Streetlab
- Responsible party
- Sponsor
- Investigators
- Saddek MOHAND-SAID, Principal investigator, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909398
- Sponsor's protocol ID
- P17-05
- Acronym
- PupDyn
- Status last verified
- May 2021
- First submitted
- 28 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04909398
- Acronym / sponsor ID
- PupDyn / P17-05
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Collaborators
- Streetlab
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic pupillometry sessions | Experimental | Behavioral: Dynamic pupillometry sessionsIt 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
- Patients must have one of three conditions: Retinitis Pigmentosa, Stargardt disease, Leber optic neuropathy.
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic pupillometry sessionsThe 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. | Behavioural | Dynamic pupillometry sessions |
Primary outcome
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
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
Related trials for Retinitis Pigmentosa
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Cell Collection to Study Eye Diseases
Retinal Disease, AMD
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingObservational study
Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants
Inherited Retinal Degeneration, Retinitis Pigmentosa
Active, not recruitingObservational study
Rate of Progression in EYS Related Retinal Degeneration
Retinitis Pigmentosa, Eye Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saddek MOHAND-SAID principal investigator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic pupillometry sessions in people with Retinitis Pigmentosa and Leber's Hereditary Optic Neuropathy, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic pupillometry sessions pupillary reflex measurement (time frame: Week 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.