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

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

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].

Study Overview

• Status: Completed
• Conditions: Glaucoma; Retinitis Pigmentosa
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémea

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum brightness value for visual comfort (THRESHOLD_MAX)		0 to 6 months
The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN)		0 to 6 months
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.	0 to 6 months
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.	0 to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Optimal range (in degrees) of the visual field provided by the device "RV glasses + camera"	0 to 6 months
Response time in seconds	0 to 6 months
Number of correct responses	0 to 6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Isabelle Marc, PhD, Laboratoire LGI2P, Ecole Nationale Supérieure des Mines; Principal Investigator: Luc Jeanjean, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): April 20, 2017
• Study Completion (Actual): May 29, 2017

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: LOCAL/2015/IMGD-01; 2016-A00099-42 (Other Identifier: RCB number)