Condition category
Eye Diseases
Date applied
05/06/2017
Date assigned
13/06/2017
Last edited
13/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Pablo Pinero

ORCID ID

Contact details

Department of Optics
Pharmacology and Anatomy
University of Alicante
Crta San Vicente del Raspeig s/n
San Vicente del Raspeig
03690
Spain

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

10/05/2016

Overall trial end date

10/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Anisometropic amblyopia
2. Age of 17 years old or more
3. Willing to perform the visual training

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

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

Trial participating centre

Commenius University
Eye Clinic Jessenius Faculty of Medicine Martin L. Novomeského 9
Bratislava
036 01
Slovakia

Trial 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

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.

IPD sharing statement:
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

Intention to publish date

01/09/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes