AmblyopiaPhase 2I-BiTNCT01702727
I-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia
A Phase 2 study testing I-BiTTM game, Non-I-BiTTM game and I-BiTTM DVD in people with Amblyopia, run by Nottingham University Hospitals NHS Trust at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- I-BiTTM game, Non-I-BiTTM game and I-BiTTM DVD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2012to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Cambridge University Hospitals NHS Trust
Cambridge, Cambridgeshire, CB2 0QQ
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
About this study
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').
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.
- Conditions
- Amblyopia
- Being tested
- I-BiTTM game, Non-I-BiTTM game, I-BiTTM DVD
- Keywords
- Amblyopia, I-BiT TM, Interactive games, Binocular
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-BiTTM gameDevice
30 minutes intervention weekly for 6 weeks.
Non-I-BiTTM gameDevice
30 minutes intervention weekly for 6 weeks.
I-BiTTM DVDDevice
30 minutes intervention weekly for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| I-BiTTM game | Experimental | 30 minutes intervention weekly for 6 weeks. Receives: Device: I-BiTTM game |
| Non-I-BiTTM game | Active comparator | 30 minutes intervention weekly for 6 weeks. Receives: Device: Non-I-BiTTM game |
| I-BiTTM DVD | Experimental | 30 minutes intervention weekly for 6 weeks. Receives: Device: I-BiTTM DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in visual acuity
Measured: 6 weeks
Secondary outcomes (1)
Change from baseline in visual acuity
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Alexander Foss, BA BMBCh MRCP MRCOphth FRC, Principal investigator, Consultant Ophthalmologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702727
- Sponsor's protocol ID
- 10OY006
- Acronym
- I-BiT
- Status last verified
- Nov 2016
- First submitted
- 8 Aug 2012
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35129211Herbison 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.
PubMed 26951772Foss 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.
PubMed 23688108
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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').
- ClinicalTrials.gov ID
- NCT01702727
- Acronym / sponsor ID
- I-BiT / 10OY006
- Conditions
- Amblyopia
- Keywords
- Amblyopia, I-BiT TM, Interactive games, Binocular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- Jun 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 8 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I-BiTTM game | Experimental | Device: I-BiTTM game30 minutes intervention weekly for 6 weeks. |
| Non-I-BiTTM game | Active comparator | Device: Non-I-BiTTM game30 minutes intervention weekly for 6 weeks. |
| I-BiTTM DVD | Experimental | Device: I-BiTTM DVD30 minutes intervention weekly for 6 weeks. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-BiTTM game30 minutes intervention weekly for 6 weeks. | Device | I-BiTTM game |
| Non-I-BiTTM game30 minutes intervention weekly for 6 weeks. | Device | Non-I-BiTTM game |
| I-BiTTM DVD30 minutes intervention weekly for 6 weeks. | Device | I-BiTTM DVD |
Primary outcome
Change from baseline in visual acuity
Time frame: 6 weeks
1 secondary outcome
Change from baseline in visual acuity
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Derived from this study: PubMed 35129211Tailor 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.
- Derived from this study: PubMed 26951772Herbison 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.
- Derived from this study: PubMed 23688108Foss 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Foss, BA BMBCh MRCP MRCOphth FRC principal investigator
Consultant Ophthalmologist
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing I-BiTTM game, Non-I-BiTTM game and I-BiTTM DVD in people with Amblyopia, run by Nottingham University Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in visual acuity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01702727, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.