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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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7 December 2020 |
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Main ID: |
ISRCTN62086471 |
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Date of registration:
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13/06/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dichoptic virtual reality training for treatment of amblyopia
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Scientific title:
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Amblyopia treatment of adults with Dichoptic training using the Virtual Reality oculus rift head mounted display: Preliminary results |
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Date of first enrolment:
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09/03/2016 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN62086471 |
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Study type:
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Interventional |
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Study design:
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Prospective interventional non randomised pilot study (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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Slovakia
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Spain
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Contacts
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Name:
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David Pablo
Pinero |
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Address:
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Department of Optics
Pharmacology and Anatomy
University of Alicante
Crta San Vicente del Raspeig s/n
03690
San Vicente del Raspeig
Spain |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Anisometropic amblyopia
2. Age of 17 years old or more
3. Willing to perform the visual training
Exclusion criteria:
1. Strabismus
2. Previous ocular surgery
3. Corneal irregularity
4. Opacification of ocular media including cataracts
5. Active ocular disease
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anisometropic amblyopia
Eye Diseases
Anisometropic amblyopia
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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University of Alicante
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Ethics review
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Status:
Approval date:
Contact:
Ethics Committe of Jessenius Medical School Commenius University, 08/03/2016, ref: EK 1795/2016
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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10/10/2016 |
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URL:
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