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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04360291
Other study ID # P19-05
Secondary ID 2019-A01198-49
Status Recruiting
Phase
First received
Last updated
Start date November 4, 2019
Est. completion date October 17, 2021

Study information

Verified date April 2020
Source Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Contact Tania RILCY
Phone +33 140021126
Email trilcy@15-20.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date October 17, 2021
Est. primary completion date September 11, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Institut de la vision Paris

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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