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Trial registered on ANZCTR


Registration number
ACTRN12617001586303
Ethics application status
Approved
Date submitted
1/11/2017
Date registered
28/11/2017
Date last updated
28/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of Adult Amblyopia with the Vivid Vision System
Scientific title
Effect of treatment with the Vivid Vision System on visual acuity in Adult Amblyopia
Secondary ID [1] 293259 0
None
Universal Trial Number (UTN)
U1111-1204-5811
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amblyopia 305309 0
Condition category
Condition code
Eye 304612 304612 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will undergo weekly sessions with a trained ophthalmic technician, optometrist or orthoptist. Each session will involve a 30-60 minute period with the patient using a commercially available virtual reality headset (the Vivid Vision System) designed for the treatment of amblyopia. Sessions will be done weekly for 6 to 12 months. The sessions will take place at the Queensland eye Institute in Brisbane. Free parking will be made available.
The primary endpoint is 12 months. If a patients achieved in improvement in visual acuity up to "normal" normal 6 on 6 vision by 6 months then that patients may stop the study then as further testing would not achieve an improvement in vision.

The headset is an "Oculus Rift" commercially available Virtual reality headset that integrates with motion sensors. The movement of the patients hands and fingers are logged by the motion sensors and integrated into what the patients sees in the headset. The experience is very immersive, Patients can not see anything in the room they are in except for what is projected inside the VR headset. Sessions can be fatiguing as the patients need to concentrate on the tasks. Initially sessions will go for 30 minutes but as the patients becomes more used to the treatment they will be allowed to increase the length of the session up to 60 minutes. The increase in length will be controlled by the patient.

The adherence to the tasks is monitored by the software in the headset, Each task is scored and the system automatically determines if the patient has removed the headset. A session will be monitored by one of the study examiners. Patients can take a short break if and when required as the system will automatically pause.
Intervention code [1] 299519 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303845 0
The outcome being measured is the number (percentage) of participants with an improvement in best corrected visual acuity of at least 2 lines of vision on an EDTRS visual acuity chart.
Timepoint [1] 303845 0
the primary endpoint is 12 months where the primary outcome will be measured. These measurement will also be performed at 6 months to document any improvements over time.
Secondary outcome [1] 340264 0
The number (percentage) of participants with an improvement in best corrected visual acuity of at least 2 lines of vision on objective electrophysiology visual acuity testing.
Timepoint [1] 340264 0
6 and 12 months

Eligibility
Key inclusion criteria
Patients with refractive amblyopia and no strabismus
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to use a virtual reality headset
Strabismus
Abnormalities in proprioception of the hands
Non-english speaking
Previous gaming addiction

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
na
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The only assessment criteria is visual acuity measured with both subjective and objective methods. Analysis is very simple, does vision improve by 2 lines on a standardised visual acuity chart of not. A statistician is available in our research institute if we require one but we feel this is unlikely,.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/12/2017
Actual
Date of last participant enrolment
Anticipated
20/12/2017
Actual
Date of last data collection
Anticipated
20/12/2018
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297888 0
Commercial sector/Industry
Name [1] 297888 0
France Medical
Country [1] 297888 0
Australia
Funding source category [2] 298022 0
Charities/Societies/Foundations
Name [2] 298022 0
Queensland Eye Institute
Country [2] 298022 0
Australia
Primary sponsor type
Individual
Name
Dr Brendan Cronin
Address
Queensland Eye Institute
140 Melbourne Street
South Brisbane Qld 4101
Country
Australia
Secondary sponsor category [1] 297095 0
None
Name [1] 297095 0
Address [1] 297095 0
Country [1] 297095 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298937 0
RANZCO
Ethics committee address [1] 298937 0
94-98 Chalmers Street Surrey Hills NSW 2010
Ethics committee country [1] 298937 0
Australia
Date submitted for ethics approval [1] 298937 0
26/07/2017
Approval date [1] 298937 0
22/08/2017
Ethics approval number [1] 298937 0
75:17

Summary
Brief summary
The Vivid Vision system is a commercially available device for the treatment of amblyopia. The system is a virtual reality headset connected to a PC with motion and hand detection software. The Vivid Vision software gives the user tasks where they must use their hands and fingers to point to or move objects that they see in the VR headset. The colour, size, contract and clarity of these objects are altered depending in the person’s performance in the tasks. The company claim that this immersive but controlled experience is extremely effective for treating amblyopia.

Vivid Vision make claims that with regular use of the system there is a benefit for children with amblyopia. These claims are reasonable and within accepted ophthalmic standards. The company also claims that the system can benefit adults with amblyopia. Such claims are contrary to the generally accepted belief that there is no treatment for adult amblyopia. It is important to subject these claims because
• If the Vivid Vision system does in fact help adults with amblyopia improve their amblyopic eye then this is a huge breakthrough. We must be able to offer adults this treatment if it is effective.
• If the Vivid Vision system is not effective then it is important that the company’s claims are subjected to closer scientific scrutiny.

The patients will be identified from the clinician's existing population of patients

Physical examination
• Patients will be examined by an ophthalmologist, Dr Brendan Cronin and an orthoptist to ensure that there is no strabismus and that none of the exclusion criteria are met. There will be a full dilated retinal examination, colour vision assessment, stereopsis testing and refraction.

Electrodiagnostics
• An objective visual acuity will be performed at the Queensland Electrodiagnostic and Imaging Clinic at 140 Melbourne Street South Brisbane.

Vivid Vision Training
• Participants will have 30-60 minutes of training on the Vivid Vision system once per week
• The system is an Oculus Rift virtual reality headset exactly like those that are used in computer game systems.



After 6 and 12 months participants will have the electrodiagnostic testing done again. At 6 and 12 months they will have an examination by Dr Cronin and an orthoptist as well for refraction and stereoacuity testing.





Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78714 0
Dr Brendan Cronin
Address 78714 0
Queensland Eye Institute
140 Melbourne Street
South Brisbane Qld 4101
Country 78714 0
Australia
Phone 78714 0
+61 7 32395000
Fax 78714 0
Email 78714 0
[email protected]
Contact person for public queries
Name 78715 0
Brett Caldwell
Address 78715 0
Queensland Eye Institute
140 Melbourne Street
South Brisbane Qld 4101
Country 78715 0
Australia
Phone 78715 0
+61 7 3239 5000
Fax 78715 0
Email 78715 0
[email protected]
Contact person for scientific queries
Name 78716 0
Brendan Cronin
Address 78716 0
Queensland Eye Institute
140 Melbourne Street
South Brisbane Qld 4101
Country 78716 0
Australia
Phone 78716 0
+61 7 3239 5000
Fax 78716 0
Email 78716 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.