Amblyopia
Conditions
Keywords
Amblyopia, I-BiT TM, Interactive games, Binocular
Brief summary
The study aims to determine whether 30 minutes of treatment playing an interactive computer game weekly for 6 weeks, improves visual acuity. The game has been specially configured to ensure the amblyopic eye is preferentially stimulated and the patient wears shutter glasses which manipulate the image seen by each eye in order to provide more information to the amblyopic eye. Patients will be randomised to play the computer game using the I-BiTTM technology, play the computer game but without the I-BiTTM technology, or watch a DVD using the I-BiTTM technology.
Interventions
DEVICEI-BiTTM game
30 minutes intervention weekly for 6 weeks.
DEVICENon-I-BiTTM game
30 minutes intervention weekly for 6 weeks.
DEVICEI-BiTTM DVD
30 minutes intervention weekly for 6 weeks.
Sponsors
Wellcome Trust
Nottingham University Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Anisometropic, Strabismic or Mixed Amblyopia as made by an Orthoptist * Male or Female * Aged 4 - 8 years inclusive. * Participant's parent or guardian is willing and able to give informed consent for participation in the study
Exclusion criteria
* Stimulus deprivation amblyopia. * Organic lesions of the eye preventing the establishment of good vision (e.g. media opacities, abnormalities in the fundus or optic nerve). * Lesions of the brain preventing the establishment of good vision (e.g. cortical visual impairment). * Patients diagnosed with Photosensitive Epilepsy * Patients diagnosed with or suspected of having Conjunctivitis * Loss of suppression at filter 4 or less as measured with the Sbisa Bar * Establishment of normal vision by refractive adaptation (wearing glasses after presentation). * Inability to comply with the follow up visits required * Refusal to accept randomisation * Have participated in a previous study examining I-BiT treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in visual acuity | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in visual acuity | 10 weeks |
Countries
United Kingdom
Outcome results
None listed