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NCT01702727

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

NCT ID: NCT01702727

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Amblyopia

Keywords

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Amblyopia I-BiT TM Interactive games Binocular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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I-BiTTM game

30 minutes intervention weekly for 6 weeks.

Group Type EXPERIMENTAL

I-BiTTM game

Intervention Type DEVICE

30 minutes intervention weekly for 6 weeks.

Non-I-BiTTM game

30 minutes intervention weekly for 6 weeks.

Group Type ACTIVE_COMPARATOR

Non-I-BiTTM game

Intervention Type DEVICE

30 minutes intervention weekly for 6 weeks.

I-BiTTM DVD

30 minutes intervention weekly for 6 weeks.

Group Type EXPERIMENTAL

I-BiTTM DVD

Intervention Type DEVICE

30 minutes intervention weekly for 6 weeks.

Interventions

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I-BiTTM game

30 minutes intervention weekly for 6 weeks.

Intervention Type DEVICE

Non-I-BiTTM game

30 minutes intervention weekly for 6 weeks.

Intervention Type DEVICE

I-BiTTM DVD

30 minutes intervention weekly for 6 weeks.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wellcome Trust

OTHER

Sponsor Role collaborator

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Foss, BA BMBCh MRCP MRCOphth FRC

Role: PRINCIPAL_INVESTIGATOR

Consultant Ophthalmologist

Locations

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Cambridge University Hospitals NHS Trust

Cambridge, Cambridgeshire, United Kingdom

Site Status

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED

PMID: 35129211 (View on PubMed)

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.

Reference Type DERIVED

PMID: 26951772 (View on PubMed)

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.

Reference Type DERIVED

PMID: 23688108 (View on PubMed)

Other Identifiers

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10OY006

Identifier Type: -

Identifier Source: org_study_id