I-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia
I-BiT
Evaluation and Development of a Novel Binocular Treatment (I-BiTTM) System Using Video Clips and Interactive Games to Improve Vision in Children With Amblyopia ('Lazy Eye').
1 other identifier
interventional
75
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2012
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 8, 2012
CompletedFirst Posted
Study publicly available on registry
October 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 22, 2016
November 1, 2016
1.4 years
August 8, 2012
November 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in visual acuity
6 weeks
Secondary Outcomes (1)
Change from baseline in visual acuity
10 weeks
Study Arms (3)
I-BiTTM game
EXPERIMENTAL30 minutes intervention weekly for 6 weeks.
Non-I-BiTTM game
ACTIVE COMPARATOR30 minutes intervention weekly for 6 weeks.
I-BiTTM DVD
EXPERIMENTAL30 minutes intervention weekly for 6 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nottingham University Hospitals NHS Trustlead
- Wellcome Trustcollaborator
Study Sites (2)
Cambridge University Hospitals NHS Trust
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
Related Publications (3)
Tailor V, Ludden S, Bossi M, Bunce C, Greenwood JA, Dahlmann-Noor A. Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years. Cochrane Database Syst Rev. 2022 Feb 7;2(2):CD011347. doi: 10.1002/14651858.CD011347.pub3.
PMID: 35129211DERIVEDHerbison N, MacKeith D, Vivian A, Purdy J, Fakis A, Ash IM, Cobb SV, Eastgate RM, Haworth SM, Gregson RM, Foss AJ. Randomised controlled trial of video clips and interactive games to improve vision in children with amblyopia using the I-BiT system. Br J Ophthalmol. 2016 Nov;100(11):1511-1516. doi: 10.1136/bjophthalmol-2015-307798. Epub 2016 Mar 7.
PMID: 26951772DERIVEDFoss AJ, Gregson RM, MacKeith D, Herbison N, Ash IM, Cobb SV, Eastgate RM, Hepburn T, Vivian A, Moore D, Haworth SM; I-BiT Steering group. Evaluation and development of a novel binocular treatment (I-BiT) system using video clips and interactive games to improve vision in children with amblyopia ('lazy eye'): study protocol for a randomised controlled trial. Trials. 2013 May 20;14:145. doi: 10.1186/1745-6215-14-145.
PMID: 23688108DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Foss, BA BMBCh MRCP MRCOphth FRC
Consultant Ophthalmologist
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2012
First Posted
October 8, 2012
Study Start
June 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 22, 2016
Record last verified: 2016-11