Clinical trial NCT02614651: AUgmented REality for the Visually Impaired - Part 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
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Glaucoma
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: The maximum brightness value for visual comfort (THRESHOLD_MAX)
timeFrame: 0 to 6 months
measure: The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN)
timeFrame: 0 to 6 months
measure: The speed of light change adaptation within a pre-specified range (getting dimmer)
timeFrame: 0 to 6 months
measure: The speed of light change adaptation within a pre-specified range (getting brighter)
timeFrame: 0 to 6 months
Secondary outcomes:
measure: Optimal range (in degrees) of the visual field provided by the device "RV glasses + camera"
timeFrame: 0 to 6 months
measure: Response time in seconds
timeFrame: 0 to 6 months
measure: Number of correct responses
timeFrame: 0 to 6 months
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémea
Study officials:
affiliation: Laboratoire LGI2P, Ecole Nationale Supérieure des Mines
name: Isabelle Marc, PhD
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Luc Jeanjean, MD
role: PRINCIPAL_INVESTIGATOR
References: