NCT04360291

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2021

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

October 23, 2019

Last Update Submit

April 21, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    through study completion,, an average of 1 year

Study Arms (2)

Healthy volunteers

Healthy volunteers

Other: Eye tracker

Retinopathy pigment

Patients with retinopathy pigment

Other: Eye tracker

Interventions

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

Healthy volunteersRetinopathy pigment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with pigmentary retinopathy

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de la vision

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Avinoam Safran

    Institut de la vision

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2019

First Posted

April 24, 2020

Study Start

November 4, 2019

Primary Completion

September 11, 2020

Study Completion

October 17, 2021

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations