AUgmented REality for the Visually Impaired - Part 1

Not Applicable

Completed

• Conditions: Retinitis Pigmentosa; Glaucoma

• Registration Number: NCT02614651
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-25
• Status Verified: 2016-05
• Study Start: 2016-05
• Primary Completion: 2017-04-20
• Study Completion: 2017-05-29
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)	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)	0 to 6 months	The pre-specified range goes from THRESHOLD_MIN up to THRESHOLD_MAX.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémea; 🇫🇷 Nîmes Cedex 09, France