Plain English Summary
Background and study aims
Anisometropic amblyopia occurs when there is an unequal focus between the eyes. It causes a reduction of the best corrected visual acuity (best distance vision) of the eye without an cause. This condition can lead to permanent vision loss in one eye and limit the vision with both eyes. The main treatments in amblyopia are for children and involve wearing an eye patch over one eye to strengthen the other eye. This treatment is thought to be only effective in the first years of life. A new method of treatment for amblyopia based on the use of a dichoptic (presenting independent and not coordinated stimulus to the eyes) games in a virtual reality environment could help amblyopia for those who are not children. This type of treatment is promising as is non-invasive, without risks associated and motivating for patient as it consists of a game. The aim of this study is to evaluate the effect of dichoptic visual training using a virtual reality head mounted display in a sample of anisometropic amblyopic adults and to evaluate the potential usefulness of this option of treatment.
Who can participate?
Adults aged 17 and older who have anisometropic amblyopia
What does the study involve?
Participants undergo an eye examine prior to the training. Participants receive dichoptic visual training using computer games and a wearable virtual reality system. Participants attend two training sessions a week for one month. Training sessions take 40 minutes and include two different types of games. Participants are followed up for stereopsis (the perception of depth) and visual acuity after their last training session and again three months later.
What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.
Where is the study run from?
1. Commenius University (Slovakia)
2. University of Alicante (Spain)
When is the study starting and how long is it expected to run for?
May 2016 to October 2016
Who is funding the study?
University of Alicante (Spain)
Who is the main contact?
Dr David Pablo Pinero
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
DVR1
Study information
Scientific title
Amblyopia treatment of adults with Dichoptic training using the Virtual Reality oculus rift head mounted display: Preliminary results
Acronym
DVR
Study hypothesis
Dichoptic visual training using a virtual reality head mounted display is able to restore visual acuity and stereopsis in adults with anisometropic amblyopia.
Ethics approval(s)
Ethics Committe of Jessenius Medical School Commenius University, 08/03/2016, ref: EK 1795/2016
Study design
Prospective interventional non randomised pilot study
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet’
Condition
Anisometropic amblyopia
Intervention
Participants all undergo a baseline ophthalmological examination including visual testing, manifest and cycloplegic refraction, cover test, four dot Worth test, anterior segment examination with the slit lamp, corneal topography and funduscopy.
Participants then undergo a dichoptic visual training was performed using the beta version of the computer game Diplopia Game which was run in the Oculus Rift OC DK2 virtual reality head mounted display. Two games are used, a space game in which subjects were flying spaceship through a system of rings and a breaker game which is a typical block breaker game, but played in a virtual reality 3D setting. Both games had a dichoptic setting in which the central part of the picture was different for each eye.
Each participant undergoes eight training sessions, being performed twice a week. Each session included 40 minutes of training with the two different games (20 minutes per game). This takes one month.
Stereopsis and visual acuity were tested after finishing the last session of training (one month after beginning the training) and three months after the end of training.
Intervention type
Device
Pharmaceutical study type(s)
Phase
Drug/device/biological/vaccine name(s)
Primary outcome measure
1. Visual acuity is measured using calibrated liquid crystal display (LCD) optotype with Snellen charts (CC-X10, Topcon, Japan) at baseline, one and three months
2. Stereopsis is measured using the Stereo Randot graded circle test (Stereo Optical, IL, USA) at baseline, one and three months
Secondary outcome measures
1. Compliance is measured using the computer registration of the training sessions at one month
2. Refraction is measured using retinoscopy and subjective refraction in trial frame at baseline, one and three months
Overall study start date
10/05/2016
Overall study end date
10/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Anisometropic amblyopia
2. Age of 17 years old or more
3. Willing to perform the visual training
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
17
Total final enrolment
17
Participant exclusion criteria
1. Strabismus
2. Previous ocular surgery
3. Corneal irregularity
4. Opacification of ocular media including cataracts
5. Active ocular disease
Recruitment start date
09/03/2016
Recruitment end date
09/05/2016
Locations
Countries of recruitment
Slovakia, Spain
Study participating centre
Commenius University
Eye Clinic Jessenius Faculty of Medicine Martin
L. Novomeského 9
Bratislava
036 01
Slovakia
Study participating centre
University of Alicante
Department of Optics, Pharmacology and Anatomy
Crta San Vicente del Raspeig s/n
San Vicente del Raspeig
Alicante
03690
Spain
Sponsor information
Organisation
Commenius University
Sponsor details
Faculty of Medicine
Špitálska 24
Bratislava
813 72
Slovakia
Sponsor type
University/education
Website
ROR
Funders
Funder type
University/education
Funder name
University of Alicante
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of the results in BMC Ophthalmology journal.
Intention to publish date
01/09/2017
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Peter Ziak, 1ziakpeter@gmail.com or David P Piñero, david.pinyero@ua.es
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/06/2017 | 26/11/2020 | Yes | No |