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

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ClinicalTrials.gov Identifier: NCT02614651
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
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].

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Glaucoma 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : May 2016
Actual Primary Completion Date : April 20, 2017
Actual Study Completion Date : May 29, 2017


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.




Primary Outcome Measures :
  1. The maximum brightness value for visual comfort (THRESHOLD_MAX) [ Time Frame: 0 to 6 months ]
  2. The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN) [ Time Frame: 0 to 6 months ]
  3. The speed of light change adaptation within a pre-specified range (getting dimmer) [ Time Frame: 0 to 6 months ]
    The pre-specified range goes from THRESHOLD_MAX down to THRESHOLD_MIN.

  4. The speed of light change adaptation within a pre-specified range (getting brighter) [ Time Frame: 0 to 6 months ]
    The pre-specified range goes from THRESHOLD_MIN up to THRESHOLD_MAX.


Secondary Outcome Measures :
  1. Optimal range (in degrees) of the visual field provided by the device "RV glasses + camera" [ Time Frame: 0 to 6 months ]
  2. Response time in seconds [ Time Frame: 0 to 6 months ]
  3. Number of correct responses [ Time Frame: 0 to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614651


Locations
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France
CHRU de Nîmes - Hôpital Universitaire Carémea
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Director: Isabelle Marc, PhD Laboratoire LGI2P, Ecole Nationale Supérieure des Mines
Principal Investigator: Luc Jeanjean, MD Centre Hospitalier Universitaire de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02614651     History of Changes
Other Study ID Numbers: LOCAL/2015/IMGD-01
2016-A00099-42 ( Other Identifier: RCB number )
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: May 2016

Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn