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

NCT01702727 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2016-11-22

No results posted yet for this 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.

Conditions

  • Amblyopia

Interventions

DEVICE

I-BiTTM game

30 minutes intervention weekly for 6 weeks.

DEVICE

Non-I-BiTTM game

30 minutes intervention weekly for 6 weeks.

DEVICE

I-BiTTM DVD

30 minutes intervention weekly for 6 weeks.

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Alexander Foss, BA BMBCh MRCP MRCOphth FRC · Consultant Ophthalmologist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01702727 on ClinicalTrials.gov