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AUgmented REality for the Visually Impaired - Part 1

Not Applicable
Completed
Conditions
Retinitis Pigmentosa
Glaucoma
Interventions
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
Registration Number
NCT02614651
Lead Sponsor
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 \[THRESHOLD_MIN-THRESHOLD_MAX\].

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
The study populationVuzix Wrap 1200DX virtural reality glassesThe 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
The study populationFind visual comfort threshold related to light intensityThe 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
The study populationPerformance of color correctionThe 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
The study populationEffectiveness of brightness controlThe 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
The study populationFind the size of the visual fieldThe 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
Primary Outcome Measures
NameTimeMethod
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 months

The 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 months

The pre-specified range goes from THRESHOLD_MIN up to THRESHOLD_MAX.

Secondary Outcome Measures
NameTimeMethod
Optimal range (in degrees) of the visual field provided by the device "RV glasses + camera"0 to 6 months
Response time in seconds0 to 6 months
Number of correct responses0 to 6 months

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémea

🇫🇷

Nîmes Cedex 09, France

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