Impact of Visual Field Restriction on Visual Exploration (REVE)

April 21, 2020 updated by: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with pigmentary retinopathy

Description

Groupe 1

Inclusion Criteria:

  • 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
  • Visit to an ophthalmologist less than a year old

Exclusion Criteria:

  • 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
  • Inability to give consent personally.
  • Adults protected by law.

Groupe 2

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy volunteers
Other: Eye tracker
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
Retinopathy pigment
Patients with retinopathy pigment
Other: Eye tracker
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
through study completion,, an average of 1 year
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.
through study completion,, an average of 1 year
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
through study completion,, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Avinoam Safran, Institut de la Vision

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 17, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P19-05
  • 2019-A01198-49 (Other Identifier: N°IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pigmentary Retinopathy

Clinical Trials on Eye tracker

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings