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

Study Overview
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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.

Official Title
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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').

Conditions
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Amblyopia

Intervention / Treatment
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* Device: I-BiTTM game
* Device: Non-I-BiTTM game
* Device: I-BiTTM DVD


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in visual acuity |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in visual acuity |  | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amblyopia, I-BiT TM, Interactive games, Binocular