Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients (VIRARE)

Our study aims to validate the relevance of a virtual reality tool (VIRARE: VIrtual REality Assisted Rehabilitation) in the assessment and rehabilitation of visually impaired subjects.

Study Overview

• Status: Completed
• Conditions: Visual Impairment
• Intervention / Treatment: Device: Virtual reality tests

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • Nîmes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient signed the consent form
• The patient is affiliated to a health insurance programme
• The patient presents ophthalmological or neurological pathologies with impact on visual function (retinopathy pigmentosa, macular dystrophy, glaucoma, age-related macular degeneration, cerebrovascular accident ...).
• The patient is visually impaired (visual acuity less than 3/10 of both eyes or concentric narrowing of the Goldmann binocular visual field or homonymous hemianopia) of category I, II, III or IV of the WHO classification.

Exclusion Criteria:

• The patient is participating in another study
• The patient is in an exclusion period determined by another study
• The patient is under safeguard of justice.
• The patient is under judicial protection.
• It is not possible to give the patient (or his/her trusted-person) informed information.
• The patient is pregnant or breastfeeding.
• The patient has a sensory or cognitive disability with a given scale (MMS < 24)
• The patient has difficulty moving including major locomotor difficulties.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: visually impaired patients

Device: Virtual reality tests; The patient will complete 3 self-questionnaires and pass 3 exploratory tests of virtual reality: 10 minutes sitting test: detection of 5 targets in a 360 ° field of vision; 10-minute stand-up motionless test: detection of 5 targets in a 360 ° field of view and placing ingredients of a recipe; Standing 10-minute test: the patient moves to the site of his mission, detection of 5 targets in a 360 ° field of vision and preparing a recipe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dizziness felt by the patient	Yes/no	Day 0
Nausea felt by the patient	Yes/no	Day 0
headache felt by the patient	Yes/no	Day 0
dazzle felt by the patient	Yes/no	Day 0
watering of the patient	Yes/no	Day 0
eye burns felt by the patient	Yes/no	Day 0
Pain due to the mobilization of the eyeballs felt by the patient	Yes/no	Day 0
Extraocular pain felt by the patient	Yes/no	Day 0
diplopia	Yes/no	Day 0
amaurosis	Yes/no	Day 0
Fear	Yes/no	Day 0
conformity of the session according to the patient point of view	Yes/no	Day 0
unpleasantness of the session from the patient point of view	Yes/no	Day 0
Difficulty of the session according to the patient point of view	Yes/no	Day 0
Willingness to continue the following tests according to the patient point of view	Yes/no	Day 0
Cervical pain felt by the patient	Yes/no	Day 0
oculomotricity of the patient according to the therapist	Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable	Day 0
head movements of the patient according to the therapist	Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable	Day 0
body movements of the patient according to the therapist	Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable	Day 0
target tracking by the patient according to the therapist	0 = 0 target detected; 1 or 2 targets detected; 3 or 4 targets detected; 5 targets detected	Day 0
Time lapse to find targets	minutes	Day 0
The patient asked for a pause during the test	Yes/no	Day 0
The patient asked to permanently stop the tests	Yes/no	Day 0
The patient went to the right place during the 3rd test	Yes/no	Day 0
The patient has correctly performed the requested task	Yes/no	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Luc JEANJEAN, Nîmes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Actual): November 12, 2021
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision, Low; Vision Disorders
• Other Study ID Numbers: IDIL/2016/LJ-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No