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

NHS Trust

Status and phase: Completed; Phase 2

Conditions: Amblyopia

Treatments: Device: I-BiTTM game; Device: I-BiTTM DVD; Device: Non-I-BiTTM game

Study type: Interventional

Funder types: Other

Identifiers

NCT01702727

10OY006

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

I-BiTTM game

Experimental group

Description:

30 minutes intervention weekly for 6 weeks.

Treatment:

Device: I-BiTTM game

Non-I-BiTTM game

Active Comparator group

Description:

30 minutes intervention weekly for 6 weeks.

Treatment:

Device: Non-I-BiTTM game

I-BiTTM DVD

Experimental group

Description:

30 minutes intervention weekly for 6 weeks.

Treatment:

Device: I-BiTTM DVD