NCT02614651

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 \[THRESHOLD\_MIN-THRESHOLD\_MAX\].

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2017

Completed
Last Updated

July 19, 2017

Status Verified

May 1, 2016

Enrollment Period

12 months

First QC Date

November 19, 2015

Last Update Submit

July 18, 2017

Conditions

Retinitis PigmentosaGlaucoma

Outcome Measures

Primary Outcomes (4)

  • 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)

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

    0 to 6 months

  • 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.

    0 to 6 months

Secondary Outcomes (3)

  • Optimal range (in degrees) of the visual field provided by the device "RV glasses + camera"

    0 to 6 months

  • Response time in seconds

    0 to 6 months

  • Number of correct responses

    0 to 6 months

Study Arms (1)

The study population

EXPERIMENTAL

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 intensityProcedure: Find the size of the visual fieldProcedure: Effectiveness of brightness controlProcedure: Performance of color correctionDevice: Vuzix Wrap 1200DX virtural reality glasses

Interventions

Find visual comfort threshold related to light intensityPROCEDURE

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.

The study population
Find the size of the visual fieldPROCEDURE

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.

The study population
Effectiveness of brightness controlPROCEDURE

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.

The study population
Performance of color correctionPROCEDURE

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.

The study population
Vuzix Wrap 1200DX virtural reality glassesDEVICE

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.

The study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • The patient is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémea

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Retinitis PigmentosaGlaucoma

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesOcular Hypertension

Study Officials

  • Isabelle Marc, PhD

    Laboratoire LGI2P, Ecole Nationale Supérieure des Mines

    STUDY DIRECTOR

  • Luc Jeanjean, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 25, 2015

Study Start

May 1, 2016

Primary Completion

April 20, 2017

Study Completion

May 29, 2017

Last Updated

July 19, 2017

Record last verified: 2016-05

Locations

FR(1)