Retinitis PigmentosaAUREVI 1NCT02614651
AUgmented REality for the Visually Impaired - Part 1
A study testing Find visual comfort threshold related to light intensity, Find the size of the visual field and Performance of color correction in people with Retinitis Pigmentosa and Glaucoma, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa, Glaucoma
- What is being tested?
- Find visual comfort threshold related to light intensity, Find the size of the visual field and Performance of color correction
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to 29 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- 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".
- 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.
- Conditions
- Retinitis Pigmentosa, Glaucoma
- Being tested
- Find visual comfort threshold related to light intensity, Find the size of the visual field, Effectiveness of brightness control, Performance of color correction, Vuzix Wrap 1200DX virtural reality glasses
- Medical subject headings
- Retinitis Pigmentosa, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Find visual comfort threshold related to light intensityProcedure or surgery
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 fieldProcedure or surgery
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 controlProcedure or surgery
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 correctionProcedure or surgery
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum brightness value for visual comfort (THRESHOLD_MAX)
Measured: 0 to 6 months
The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN)
Measured: 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.
Measured: 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.
Measured: 0 to 6 months
Secondary outcomes (3)
Optimal range (in degrees) of the visual field provided by the device "RV glasses + camera"
Measured: 0 to 6 months
Response time in seconds
Measured: 0 to 6 months
Number of correct responses
Measured: 0 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startMay 2016
- Primary completion20 Apr 2017
- Study completion29 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Marc, PhD, Study director, Laboratoire LGI2P, Ecole Nationale Supérieure des MinesLuc Jeanjean, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614651
- Sponsor's protocol ID
- LOCAL/2015/IMGD-01
- Other IDs
- 2016-A00099-42
- Acronym
- AUREVI 1
- Status last verified
- May 2016
- First submitted
- 19 Nov 2015
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02614651
- Acronym / sponsor ID
- AUREVI 1 / LOCAL/2015/IMGD-01
- Conditions
- Retinitis Pigmentosa, Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 29 May 2017 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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".
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | Experimental | 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 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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°,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Find visual comfort threshold related to light intensityIn 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 or surgery | The study population |
| Find the size of the visual fieldFor 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 or surgery | The study population |
| Effectiveness of brightness controlDuring 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 or surgery | The study population |
| Performance of color correctionDuring 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. | Procedure or surgery | The study population |
| Vuzix Wrap 1200DX virtural reality glassesThe 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. | Device | The study population |
Primary outcome
The maximum brightness value for visual comfort (THRESHOLD_MAX)
Time frame: 0 to 6 months
The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN)
Time frame: 0 to 6 months
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.
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.
3 secondary outcomes
Optimal range (in degrees) of the visual field provided by the device "RV glasses + camera"
Time frame: 0 to 6 months
Response time in seconds
Time frame: 0 to 6 months
Number of correct responses
Time frame: 0 to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Marc, PhD study director
Laboratoire LGI2P, Ecole Nationale Supérieure des Mines
Luc Jeanjean, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Find visual comfort threshold related to light intensity, Find the size of the visual field and Performance of color correction in people with Retinitis Pigmentosa and Glaucoma, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum brightness value for visual comfort (THRESHOLD_MAX) (time frame: 0 to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.