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CompletedNCT02614651AUREVI 1Updated Jul 19, 2017

AUgmented REality for the Visually Impaired - Part 1

An interventional study of Find visual comfort threshold related to light intensity and Find the size of the visual field in Retinitis Pigmentosa and Glaucoma, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-19.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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].
Read the 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.
02

Conditions studied

  • Retinitis Pigmentosa
  • Glaucoma
03

In context

Retinitis Pigmentosa

273 studies on the registry are indexed under Retinitis Pigmentosa; 71 are open to participants now.

This study's enrollment of 15 is below the median of 27 across 177 interventional studies indexed under Retinitis Pigmentosa.

Browse Retinitis Pigmentosa studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 594 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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 · 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

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.

06

What researchers measure

Primary outcomes

  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)

    The pre-specified range goes from THRESHOLD\_MAX down to THRESHOLD\_MIN.

    Time frame: 0 to 6 months

  4. 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.

    Time frame: 0 to 6 months

Secondary outcomes

  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

07

Study locations

1 site
  • CHRU de Nîmes - Hôpital Universitaire Carémea
    Nîmes, 30029, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02614651
Responsible party
Sponsor
First posted
Nov 25, 2015
Start date
May 2016
Primary completion
Apr 20, 2017
Completion
May 29, 2017
Last update
Jul 19, 2017

Study contacts

Isabelle Marc, PhD
study director · Laboratoire LGI2P, Ecole Nationale Supérieure des Mines
Luc Jeanjean, MD
principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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