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

Amblyopia Clinical Trial

— I-BiT  

Official title:

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').

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702727
• Other study ID #: 10OY006
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2012
• Last updated: November 21, 2016
• Start date: June 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2016
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• I-BiTTM game
30 minutes intervention weekly for 6 weeks.
• Non-I-BiTTM game
30 minutes intervention weekly for 6 weeks.
• I-BiTTM DVD
30 minutes intervention weekly for 6 weeks.

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Trust	Cambridge	Cambridgeshire
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust	Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in visual acuity		6 weeks	No
Secondary	Change from baseline in visual acuity		10 weeks	No

External Links

•   Project website