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Completed

NCT Number: NCT02614651

AUgmented REality for the Visually Impaired - Part 1

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].

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Glaucoma Ocular Hypertension Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémea

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Find visual comfort threshold related to light intensity

Procedure

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

Procedure

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

Procedure

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

Procedure

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.

Vuzix Wrap 1200DX virtural reality glasses

Device

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 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)

    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 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: AUREVI 1

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 25, 2015
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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