None listed
Conditions
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.
Interventions
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 p
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.
Sponsors
Dr Brendan Cronin
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with refractive amblyopia and no strabismus
Exclusion criteria
Inability to use a virtual reality headset Strabismus Abnormalities in proprioception of the hands Non-english speaking Previous gaming addiction
Outcome results
None listed