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AUgmented REality for the Visually Impaired - Part 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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02614651
Acronym
AUREVI 1
Enrollment
15
Registered
2015-11-25
Start date
2016-05-31
Completion date
2017-05-29
Last updated
2017-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Retinitis Pigmentosa

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.

Interventions

PROCEDUREFind 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.

PROCEDUREFind 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.

PROCEDUREEffectiveness 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.

PROCEDUREPerformance 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.

DEVICEVuzix 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 monthsThe 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 monthsThe pre-specified range goes from THRESHOLD\_MIN up to THRESHOLD\_MAX.

Secondary

MeasureTime frame
Response time in seconds0 to 6 months
Number of correct responses0 to 6 months
Optimal range (in degrees) of the visual field provided by the device RV glasses + camera0 to 6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026