Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
15 participants
INTERVENTIONAL
2016-05-31
2017-05-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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 \[THRESHOLD\_MIN-THRESHOLD\_MAX\].
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues
NCT04714424
Assessment of an Augmented Reality Low Visual Aid in Children and Young People With Visual Impairment
NCT05201482
Feasibility and Tolerability Study of Smart Contact Lens With Healthy Subjects and Patients With Stargardt's Disease
NCT06989658
Performance of Refractometers With Self-adjusting Lenses Compared to Cycloplegia in Children (REFRALENS)
NCT06668246
Digital Defocus Vision Training (DDVT) System Development and Application
NCT07042022
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Find 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.
Find 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.
Effectiveness 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.
Performance 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.
Vuzix 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Find 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.
Find 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.
Effectiveness 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.
Performance 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.
Vuzix 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Isabelle Marc, PhD
Role: STUDY_DIRECTOR
Laboratoire LGI2P, Ecole Nationale Supérieure des Mines
Luc Jeanjean, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nîmes
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHRU de Nîmes - Hôpital Universitaire Carémea
Nîmes, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-A00099-42
Identifier Type: OTHER
Identifier Source: secondary_id
LOCAL/2015/IMGD-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.