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CompletedNCT01702727I-BiTUpdated Nov 22, 2016

I-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia

A Phase 2 interventional study of I-BiTTM game and Non-I-BiTTM game in Amblyopia, sponsored by Nottingham University Hospitals NHS Trust. Completed at 2 sites in United Kingdom. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2016-11-22.

Sponsored by Nottingham University Hospitals NHS Trust · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
4 Years to 8 Years
Sex
All
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Study 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.

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Conditions studied

  • Amblyopia

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Keywords

  • Amblyopia
  • I-BiT TM
  • Interactive games
  • Binocular
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In context

Amblyopia

183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.

This study's enrollment of 75 is above the median of 60 across 133 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

Nottingham University Hospitals NHS Trust is the lead sponsor of 104 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    I-BiTTM game

    30 minutes intervention weekly for 6 weeks.

    Device: I-BiTTM game

  • Active comparator
    Non-I-BiTTM game

    30 minutes intervention weekly for 6 weeks.

    Device: Non-I-BiTTM game

  • Experimental
    I-BiTTM DVD

    30 minutes intervention weekly for 6 weeks.

    Device: I-BiTTM DVD

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.

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What researchers measure

Primary outcomes

  1. Change from baseline in visual acuity

    Time frame: 6 weeks

Secondary outcomes

  1. Change from baseline in visual acuity

    Time frame: 10 weeks

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Study locations

2 sites
  • Cambridge University Hospitals NHS Trust
    Cambridge, Cambridgeshire CB2 0QQ, United Kingdom
  • Nottingham University Hospitals NHS Trust
    Nottingham, Nottinghamshire NG7 2UH, United Kingdom
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References and documents

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 35129211 ↗
  • 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. PubMed 26951772 ↗
  • 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. PubMed 23688108 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01702727
Lead sponsor
Nottingham University Hospitals NHS Trust
Collaborators
Wellcome Trust
Responsible party
Sponsor
First posted
Oct 8, 2012
Start date
Jun 2012
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Nov 22, 2016

Study contacts

Alexander Foss, BA BMBCh MRCP MRCOphth FRC
principal investigator · Consultant Ophthalmologist

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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