ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

U1111-1204-5811

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Amblyopia

Condition category

Condition code

Eye

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]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

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?

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)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

France Medical

Address [1]

16/35 Paringa Rd, Murarrie QLD 4172

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Queensland Eye Institute

Address [2]

140 Melbourne Street
South Brisbane Qld 4101

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RANZCO

Ethics committee address [1]

94-98 Chalmers Street Surrey Hills NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/07/2017

Approval date [1]

22/08/2017

Ethics approval number [1]

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

Dr Brendan Cronin

Address

Queensland Eye Institute
140 Melbourne Street
South Brisbane Qld 4101

Country

Australia

Phone

+61 7 32395000

Fax

brendan.cronin@qei.org.au

Contact person for public queries

Name

Brett Caldwell

Address

Queensland Eye Institute
140 Melbourne Street
South Brisbane Qld 4101

Country

Australia

Phone

+61 7 3239 5000

Fax

brett.caldwell@qei.org.au

Contact person for scientific queries

Name

Brendan Cronin

Address

Queensland Eye Institute
140 Melbourne Street
South Brisbane Qld 4101

Country

Australia

Phone

+61 7 3239 5000

Fax

brendan.cronin@qei.org.au

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically