AUgmented REality for the Visually Impaired - Part 1 (AUREVI 1)
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|ClinicalTrials.gov Identifier: NCT02614651|
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : July 19, 2017
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].
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa Glaucoma||Procedure: Find visual comfort threshold related to light intensity Procedure: Find the size of the visual field Procedure: Effectiveness of brightness control Procedure: Performance of color correction Device: Vuzix Wrap 1200DX virtural reality glasses||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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 Start Date :||May 2016|
|Actual Primary Completion Date :||April 20, 2017|
|Actual Study Completion Date :||May 29, 2017|
Experimental: The study population
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
Procedure: Find visual comfort threshold related to light intensity
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.
Procedure: Find the size of the visual field
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.
Procedure: Effectiveness of brightness control
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.
Procedure: Performance of color correction
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.
Device: Vuzix Wrap 1200DX virtural reality glasses
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.
- The maximum brightness value for visual comfort (THRESHOLD_MAX) [ Time Frame: 0 to 6 months ]
- The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN) [ Time Frame: 0 to 6 months ]
- The speed of light change adaptation within a pre-specified range (getting dimmer) [ Time Frame: 0 to 6 months ]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) [ Time Frame: 0 to 6 months ]The pre-specified range goes from THRESHOLD_MIN up to THRESHOLD_MAX.
- Optimal range (in degrees) of the visual field provided by the device "RV glasses + camera" [ Time Frame: 0 to 6 months ]
- Response time in seconds [ Time Frame: 0 to 6 months ]
- Number of correct responses [ Time Frame: 0 to 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614651
|CHRU de Nîmes - Hôpital Universitaire Carémea|
|Nîmes Cedex 09, France, 30029|
|Study Director:||Isabelle Marc, PhD||Laboratoire LGI2P, Ecole Nationale Supérieure des Mines|
|Principal Investigator:||Luc Jeanjean, MD||Centre Hospitalier Universitaire de Nîmes|