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AUgmented REality for the Visually Impaired - Part 1 (AUREVI 1)

Primary Purpose

Retinitis Pigmentosa, Glaucoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Find visual comfort threshold related to light intensity
Find the size of the visual field
Effectiveness of brightness control
Performance of color correction
Vuzix Wrap 1200DX virtural reality glasses
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Retinitis Pigmentosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The subject is suffering from retinitis pigmentosa or glaucoma with concentric visual field constriction and presents with:
  • An acuity in the better eye superior or equal to 1/10 in near vision,
  • A binocular field of between 1° and 30°,
  • A good central fixation, absence of central scotoma,
  • Motor capability for using a computer keyboard with one hand.

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, or under guardianship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • Subjects with (or evolving toward) a multiple sensory disability, or one including cognitive disorders

Sites / Locations

  • CHRU de Nîmes - Hôpital Universitaire Carémea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The study population

Arm Description

The study population consists of subjects with a concentric constriction of the visual field (retinitis pigmentosa, glaucoma) whose motor capacity allows the use of a computer keyboard with one hand. Subjects are recruited on a voluntary basis, from information disseminated to professionals in the rehabilitation of functional low vision and patient associations, in the Ophthalmology Service of the University Hospital of Nimes and within the ARAMAV Institute. Intervention: Find visual comfort threshold related to light intensity Intervention: Find the size of the visual field Intervention: Effectiveness of brightness control Intervention: Performance of color correction Intervention: Vuzix Wrap 1200DX virtural reality glasses

Outcomes

Primary Outcome Measures

The maximum brightness value for visual comfort (THRESHOLD_MAX)
The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN)
The speed of light change adaptation within a pre-specified range (getting dimmer)
The pre-specified range goes from THRESHOLD_MAX down to THRESHOLD_MIN.
The speed of light change adaptation within a pre-specified range (getting brighter)
The pre-specified range goes from THRESHOLD_MIN up to THRESHOLD_MAX.

Secondary Outcome Measures

Optimal range (in degrees) of the visual field provided by the device "RV glasses + camera"
Response time in seconds
Number of correct responses

Full Information

First Posted
November 19, 2015
Last Updated
July 18, 2017
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02614651
Brief Title
AUgmented REality for the Visually Impaired - Part 1
Acronym
AUREVI 1
Official Title
Prospective Pilot Study on the Quantitative Evaluation of Vision Parameters Needed by Virtual Reality Goggle Displays for Subjects With Concentric Visual Field Constriction. AUgmented REality for the Visually Impaired - Part 1
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
May 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to quantify vision parameters in subjects with concentric visual field constriction, and this in relation to the display on virtual reality goggles. More specifically: The maximum brightness value for visual comfort (THRESHOLD_MAX) The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN) The speed of light change adaptation in the range [THRESHOLD_MAX-THRESHOLD_MIN] and [THRESHOLD_MIN-THRESHOLD_MAX].
Detailed Description
Secondary objectives are to: A. Quantifying the device parameters "RV glasses + camera" depending on visual acuity and the visual field of each subject: Optimal extent of the visual field provided by the device "RV glasses + camera". B. Measuring the effectiveness of different image processing algorithms used in the development of the software part of this technical assist device: Capture and display HDR images (High Dynamic Range) Color adjustment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa, Glaucoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The study population
Arm Type
Experimental
Arm Description
The study population consists of subjects with a concentric constriction of the visual field (retinitis pigmentosa, glaucoma) whose motor capacity allows the use of a computer keyboard with one hand. Subjects are recruited on a voluntary basis, from information disseminated to professionals in the rehabilitation of functional low vision and patient associations, in the Ophthalmology Service of the University Hospital of Nimes and within the ARAMAV Institute. Intervention: Find visual comfort threshold related to light intensity Intervention: Find the size of the visual field Intervention: Effectiveness of brightness control Intervention: Performance of color correction Intervention: Vuzix Wrap 1200DX virtural reality glasses
Intervention Type
Procedure
Intervention Name(s)
Find visual comfort threshold related to light intensity
Intervention Description
In this testing session, the patient's visual comfort threshold related to light intensity will be determined. Test sessions are kept under 45 minutes. The subject is sitting in front of a keyboard and a computer screen. He/she is invited to recognize letters successively displayed in the center of the screen, this center is marked with a black cross. Each letter appearance is preceded by a beep. The subject must click on the "space" bar on the keyboard as soon as he/she recognizes the letter, then gives his/her answer orally.
Intervention Type
Procedure
Intervention Name(s)
Find the size of the visual field
Intervention Description
For these tests, the subject is seated at a table, 1.5m from a wall. It features a computer keyboard. It projects an image on the wall, using to a video projector. An image moving towards a target (along 16 different trajectories) is used to evaluate the size of the visual field.
Intervention Type
Procedure
Intervention Name(s)
Effectiveness of brightness control
Intervention Description
During this testing session, the investigators seek to evaluate the effectiveness of the algorithms used to control the brightness. The subject is in a room with four different computers. The subject is asked to identify the objects displayed on different computer monitors in the room: he/she must press a key on the keyboard when he/she detects an object and state aloud the nature of the object.
Intervention Type
Procedure
Intervention Name(s)
Performance of color correction
Intervention Description
During this session, the investigators try to assess the performance for the color vision correction (saturation and hue). The subject, while wearing the virtual reality glasses + camera performs a test (twice) that requires matching colored dots (i.e. a Farnsworth test) under controlled light conditions.
Intervention Type
Device
Intervention Name(s)
Vuzix Wrap 1200DX virtural reality glasses
Intervention Description
The other interventions are performed with the use of virtual reality glasses, specifically the Vuzix Wrap 1200DX. In case of technical difficulties, the latter can be swapped with the Oculus Rift model or another model. The associated webcameras are from Logitech, and the exact model used can vary and does not carry any importance for this research.
Primary Outcome Measure Information:
Title
The maximum brightness value for visual comfort (THRESHOLD_MAX)
Time Frame
0 to 6 months
Title
The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN)
Time Frame
0 to 6 months
Title
The speed of light change adaptation within a pre-specified range (getting dimmer)
Description
The pre-specified range goes from THRESHOLD_MAX down to THRESHOLD_MIN.
Time Frame
0 to 6 months
Title
The speed of light change adaptation within a pre-specified range (getting brighter)
Description
The pre-specified range goes from THRESHOLD_MIN up to THRESHOLD_MAX.
Time Frame
0 to 6 months
Secondary Outcome Measure Information:
Title
Optimal range (in degrees) of the visual field provided by the device "RV glasses + camera"
Time Frame
0 to 6 months
Title
Response time in seconds
Time Frame
0 to 6 months
Title
Number of correct responses
Time Frame
0 to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The subject is suffering from retinitis pigmentosa or glaucoma with concentric visual field constriction and presents with: An acuity in the better eye superior or equal to 1/10 in near vision, A binocular field of between 1° and 30°, A good central fixation, absence of central scotoma, Motor capability for using a computer keyboard with one hand. Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, or under guardianship The patient refuses to sign the consent It is impossible to correctly inform the patient Subjects with (or evolving toward) a multiple sensory disability, or one including cognitive disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Marc, PhD
Organizational Affiliation
Laboratoire LGI2P, Ecole Nationale Supérieure des Mines
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luc Jeanjean, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémea
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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AUgmented REality for the Visually Impaired - Part 1

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