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

November 21, 2016 updated by: Nottingham University Hospitals NHS Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I-BiTTM game
30 minutes intervention weekly for 6 weeks.
Device: I-BiTTM game
30 minutes intervention weekly for 6 weeks.
Active Comparator: Non-I-BiTTM game
30 minutes intervention weekly for 6 weeks.
Device: Non-I-BiTTM game
30 minutes intervention weekly for 6 weeks.
Experimental: I-BiTTM DVD
30 minutes intervention weekly for 6 weeks.
Device: I-BiTTM DVD
30 minutes intervention weekly for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in visual acuity
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in visual acuity
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Collaborators

Wellcome Trust

Investigators

  • Principal Investigator: Alexander Foss, BA BMBCh MRCP MRCOphth FRC, CONSULTANT OPHTHALMOLOGIST

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

October 5, 2012

First Posted (Estimate)

October 8, 2012

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10OY006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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