Pigmentary RetinopathyREVENCT04360291
Impact of Visual Field Restriction on Visual Exploration
An observational study of Pigmentary Retinopathy, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
Trial summary
To communicate with the observer and guide his gaze on the canvas, painters have developed different stylistic processes that artists, in the manner of scientists, have acquired on the functioning of human visual perception. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pigmentary Retinopathy
- What is being tested?
- Eye tracker
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2019to 17 Oct 2021
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with pigmentary retinopathy
Who may be able to join
- no visual pathology
- Age ≥ 18 and <65 years
- Binocular visual acuity ≥8 / 10th or ≤ +0.10 logMAR
- Comprehension of the written and spoken French language
- Signed consent to participate in the study
- Health insurance affiliation
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- Visit to an ophthalmologist less than a year old
- Retinopathy pigmentary dystrophy rods-cones.
- Binocular visual acuity ≥4 / 10 (≤0.4 logMAR).
- Horizontal diameter of the residual Goldmann field of view ≤ 25 ° of binocular diameter at III4.
- Comprehension of the French language, written or oral.
- Signed consent
- Visual assessment less than 6 months old
Who cannot join
- Pregnant or lactating woman
- Ocular pathology that may interfere with planned assessments
- Treatment that may interfere with planned assessments
- Participation in another study that may interfere with this study.
- Severe pathology unbalanced or interfering with planned assessments.
- Neurological deficit including history of epileptic pathology, photosensitive epilepsy, sensory-motor coordination disorders, vestibular or cerebellar pathology
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- Inability to give consent personally.
- Adults protected by law.
- Groupe 2
- Pregnant or nursing woman.
- Ocular pathology that may interfere with planned assessments.
- Treatment that may interfere with planned assessments.
- Severe pathology unbalanced or interfering with planned assessments.
- Participation in another study that may interfere with this study.
- Neurological deficit including antecedent of epileptic pathology, photosensitive epilepsies, non-visual sensory disturbances, motor disorders, or sensorimotor coordination disorders, vestibular or cerebellar pathology.
- Inability to give consent personally.
- Adults protected by law.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut de la vision
Paris, 75012
Avinoam Safran, absafran@gmail.com
Alexis Defer, 0153462704, alexis.defer@streetlab-vision.com
About this study
Official title: Impact de la Restriction du Champ Visuel Sur l'Exploration Visuelle
To communicate with the observer and guide his gaze on the canvas, painters have developed different stylistic processes that artists, in the manner of scientists, have acquired on the functioning of human visual perception. This direct communication between the artist and the observer is strongly impacted for people with visual impairments.
In order to improve the accessibility and autonomy of visually impaired people in museums and to allow each observer to feel the visual and emotional experience closest to the original work of the artist, it is essential to identify the modifications. perceptive generated by the constriction of vision
Read the detailed description
In this experiment, the investigators study the adaptive strategies developed by people with retinitis pigmentosa in the perception of figurative works of art. Peripheral vision is crucial for detecting objects and directing attention to the relevant areas of the environment, while central vision, of high spatial resolution, is especially essential for identifying the nature of objects. The integration of perceived information in peripheral vision and central vision makes it possible to quickly and effortlessly develop a spatial representation of the environment, to activate categorical knowledge on the observed scene and to relate the various objects perceived. However, with the progressive constriction of the visual field, the visual exploration of the subject RP can not be carried out with the strategies used by the healthy subjects, in which the targets of the saccades are in particular determined according to the information perceived in peripheral vision.
Through the recording of eye movements, the investigators compare the differences in visual explorations of people with retinitis pigmentosa and healthy people with or without a simulated deficit.
- Conditions
- Pigmentary Retinopathy
- Being tested
- Eye tracker
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye trackerOther
In visual search tasks, participants will sit in front of a screen and observe during each visual scene for a maximum of 45 seconds. Their eye movements will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volunteers Receives: Other: Eye tracker | |
| Retinopathy pigment | Patients with retinopathy pigment Receives: Other: Eye tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye movements
Eye movements will be recorded by an eye trackervisual impairment whose peripheral visual field is masked
They will be invited to observe scenes of human interaction presented on photographs, pictorial works or artificial scenes with or without prior instruction.
In addition to the elementary variables recorded during the exploration by these subjects, such as the number, the amplitude or the orientation of the saccades, the sequence of fixations will be analyzed to define the exploratory strategy used.
Measured: through study completion,, an average of 1 year
Fixation strategy
The fixation strategy characterized by the path of the gaze of the subjects on the screen to locate the targets.
Measured: through study completion,, an average of 1 year
Target location accuracy
Target location accuracy, defined by the distance between the point of re-fixation on the target and the actual position of the target
Measured: through study completion,, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start4 Nov 2019
- Primary completion11 Sep 2020 (estimated)
- Study completion17 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmentary RetinopathyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avinoam Safran, Principal investigator, Institut de la vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360291
- Sponsor's protocol ID
- P19-05
- Other IDs
- 2019-A01198-49
- Acronym
- REVE
- Status last verified
- Apr 2020
- First submitted
- 23 Oct 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact de la Restriction du Champ Visuel Sur l'Exploration Visuelle
- ClinicalTrials.gov ID
- NCT04360291
- Acronym / sponsor ID
- REVE / P19-05
- Conditions
- Pigmentary Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 11 Sep 2020 (estimated)
- Study completion
- 17 Oct 2021 (estimated)
- First posted
- 24 Apr 2020 (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.
To communicate with the observer and guide his gaze on the canvas, painters have developed different stylistic processes that artists, in the manner of scientists, have acquired on the functioning of human visual perception. This direct communication between the artist and the observer is strongly impacted for people with visual impairments.
In order to improve the accessibility and autonomy of visually impaired people in museums and to allow each observer to feel the visual and emotional experience closest to the original work of the artist, it is essential to identify the modifications. perceptive generated by the constriction of vision
Detailed description
In this experiment, the investigators study the adaptive strategies developed by people with retinitis pigmentosa in the perception of figurative works of art. Peripheral vision is crucial for detecting objects and directing attention to the relevant areas of the environment, while central vision, of high spatial resolution, is especially essential for identifying the nature of objects. The integration of perceived information in peripheral vision and central vision makes it possible to quickly and effortlessly develop a spatial representation of the environment, to activate categorical knowledge on the observed scene and to relate the various objects perceived. However, with the progressive constriction of the visual field, the visual exploration of the subject RP can not be carried out with the strategies used by the healthy subjects, in which the targets of the saccades are in particular determined according to the information perceived in peripheral vision.
Through the recording of eye movements, the investigators compare the differences in visual explorations of people with retinitis pigmentosa and healthy people with or without a simulated deficit.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: Eye trackerHealthy volunteers |
| Retinopathy pigment | – | Other: Eye trackerPatients with retinopathy pigment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with pigmentary retinopathy
Key inclusion criteria (13 listed)
- no visual pathology
- Age ≥ 18 and <65 years
- Binocular visual acuity ≥8 / 10th or ≤ +0.10 logMAR
- Comprehension of the written and spoken French language
- Signed consent to participate in the study
Key exclusion criteria (17 listed)
- Pregnant or lactating woman
- Ocular pathology that may interfere with planned assessments
- Treatment that may interfere with planned assessments
- Participation in another study that may interfere with this study.
- Severe pathology unbalanced or interfering with planned assessments.
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 |
|---|---|---|
| Eye trackerIn visual search tasks, participants will sit in front of a screen and observe during each visual scene for a maximum of 45 seconds. Their eye movements will be recorded | Other | Healthy volunteers, Retinopathy pigment |
Primary outcome
Eye movements
Time frame: through study completion,, an average of 1 year
Eye movements will be recorded by an eye trackervisual impairment whose peripheral visual field is masked They will be invited to observe scenes of human interaction presented on photographs, pictorial works or artificial scenes with or without prior instruction. In addition to the elementary variables recorded during the exploration by these subjects, such as the number, the amplitude or the orientation of the saccades, the sequence of fixations will be analyzed to define the exploratory strategy used.
Fixation strategy
Time frame: through study completion,, an average of 1 year
The fixation strategy characterized by the path of the gaze of the subjects on the screen to locate the targets.
Target location accuracy
Time frame: through study completion,, an average of 1 year
Target location accuracy, defined by the distance between the point of re-fixation on the target and the actual position of the target
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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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.
Avinoam Safran principal investigator
Institut de la vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pigmentary Retinopathy, 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 13 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tania RILCY (+33 140021126, trilcy@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye movements (time frame: through study completion,, an average of 1 year). The study lists 3 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 24 Apr 2020.