Back to resultsI-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia (I-BiT)
Primary Purpose
Amblyopia
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
I-BiTTM game
Non-I-BiTTM game
I-BiTTM DVD
Sponsored by
About this trial
This is an interventional treatment trial for Amblyopia focused on measuring Amblyopia, I-BiT TM, Interactive games, Binocular
Eligibility Criteria
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
Sites / Locations
- Cambridge University Hospitals NHS Trust
- Nottingham University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
I-BiTTM game
Non-I-BiTTM game
I-BiTTM DVD
Arm Description
30 minutes intervention weekly for 6 weeks.
30 minutes intervention weekly for 6 weeks.
30 minutes intervention weekly for 6 weeks.
Outcomes
Primary Outcome Measures
Change from baseline in visual acuity
Secondary Outcome Measures
Change from baseline in visual acuity
Full Information
NCT ID
NCT01702727
First Posted
August 8, 2012
Last Updated
November 21, 2016
Sponsor
Nottingham University Hospitals NHS Trust
Collaborators
Wellcome Trust
1. Study Identification
Unique Protocol Identification Number
NCT01702727
Brief Title
I-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia
Acronym
I-BiT
Official Title
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').
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust
Collaborators
Wellcome Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
Amblyopia, I-BiT TM, Interactive games, Binocular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I-BiTTM game
Arm Type
Experimental
Arm Description
30 minutes intervention weekly for 6 weeks.
Arm Title
Non-I-BiTTM game
Arm Type
Active Comparator
Arm Description
30 minutes intervention weekly for 6 weeks.
Arm Title
I-BiTTM DVD
Arm Type
Experimental
Arm Description
30 minutes intervention weekly for 6 weeks.
Intervention Type
Device
Intervention Name(s)
I-BiTTM game
Intervention Description
30 minutes intervention weekly for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Non-I-BiTTM game
Intervention Description
30 minutes intervention weekly for 6 weeks.
Intervention Type
Device
Intervention Name(s)
I-BiTTM DVD
Intervention Description
30 minutes intervention weekly for 6 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in visual acuity
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in visual acuity
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Foss, BA BMBCh MRCP MRCOphth FRC
Organizational Affiliation
Consultant Ophthalmologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge University Hospitals NHS Trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35129211
Citation
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.
Results Reference
derived
PubMed Identifier
26951772
Citation
Herbison 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.
Results Reference
derived
PubMed Identifier
23688108
Citation
Foss 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.
Results Reference
derived
Learn more about this trial
I-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia
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