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

Phase 2

Completed

• Conditions: Amblyopia
• Interventions: Device: I-BiTTM DVD; Device: Non-I-BiTTM game; Device: I-BiTTM game

• Registration Number: NCT01702727
• Lead Sponsor: Nottingham University Hospitals NHS Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-10-05
• Study First Posted: 2012-10-08
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-BiTTM DVD	I-BiTTM DVD	30 minutes intervention weekly for 6 weeks.
Non-I-BiTTM game	Non-I-BiTTM game	30 minutes intervention weekly for 6 weeks.
I-BiTTM game	I-BiTTM game	30 minutes intervention weekly for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline in visual acuity	6 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in visual acuity	10 weeks

Trial Locations

Locations (2)

Cambridge University Hospitals NHS Trust; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom