AUgmented REality for the Visually Impaired - Part 1

Glaucoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614651
• Other study ID #: LOCAL/2015/IMGD-01
• Secondary ID: 2016-A00099-42
• Status: Completed
• Phase: N/A
• First received: November 19, 2015
• Last updated: July 18, 2017
• Start date: May 2016
• Est. completion date: May 29, 2017

Study information

• Verified date: May 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 29, 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Retinitis
• Retinitis Pigmentosa

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémea	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum brightness value for visual comfort (THRESHOLD_MAX)		0 to 6 months
Primary	The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN)		0 to 6 months
Primary	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
Primary	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	Optimal range (in degrees) of the visual field provided by the device "RV glasses + camera"		0 to 6 months
Secondary	Response time in seconds		0 to 6 months
Secondary	Number of correct responses		0 to 6 months