I-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia
This study is currently recruiting participants.
Verified October 2012 by Nottingham University Hospitals NHS Trust
Sponsor:
Nottingham University Hospitals NHS Trust
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01702727
First received: August 8, 2012
Last updated: October 5, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Amblyopia |
Device: I-BiTTM game Device: Non-I-BiTTM game Device: I-BiTTM DVD |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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'). |
Further study details as provided by Nottingham University Hospitals NHS Trust:
Primary Outcome Measures:
- Change from baseline in visual acuity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in visual acuity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I-BiTTM game
30 minutes intervention weekly for 6 weeks.
|
Device: I-BiTTM game
30 minutes intervention weekly for 6 weeks.
|
|
Active Comparator: Non-I-BiTTM game
30 minutes intervention weekly for 6 weeks.
|
Device: Non-I-BiTTM game
30 minutes intervention weekly for 6 weeks.
|
|
Experimental: I-BiTTM DVD
30 minutes intervention weekly for 6 weeks.
|
Device: I-BiTTM DVD
30 minutes intervention weekly for 6 weeks.
|
Eligibility| Ages Eligible for Study: | 4 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702727
Contacts
| Contact: Alexander Foss, BA BMBCh MRCP MRCOphth FRC | 0115 924 9924 | Alexander.Foss@nuh.nhs.uk |
| Contact: Daisy MacKeith, BA, BSc | 0115 9709750 | Daisy.mackeith@nuh.nhs.uk |
Locations
| United Kingdom | |
| Cambridge University Hospitals NHS Trust | Not yet recruiting |
| Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ | |
| Contact: Anthony Vivian, BSc MBBS FRCS FRCOphth vivianeye@aol.com | |
| Contact: Daisy McKeith, BA, BSc Daisy.mackeith@nuh.nhs.uk | |
| Nottingham University Hospitals NHS Trust | Recruiting |
| Nottingham, Nottinghamshire, United Kingdom, NG7 2UH | |
| Contact: Alexander Foss, BA BMBCh MRCP MRCOphth FRC 0115 924 9924 Alexander.Foss@nuh.nhs.uk | |
| Contact: Daisy McKeith, BA, BSc 0115 9709750 Daisy.mackeith@nuh.nhs.uk | |
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
Wellcome Trust
Investigators
| Principal Investigator: | Alexander Foss, BA BMBCh MRCP MRCOphth FRC | Consultant Ophthalmologist |
More Information
Additional Information:
No publications provided
| Responsible Party: | Nottingham University Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01702727 History of Changes |
| Other Study ID Numbers: | 10OY006 |
| Study First Received: | August 8, 2012 |
| Last Updated: | October 5, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Nottingham University Hospitals NHS Trust:
|
Amblyopia I-BiT TM Interactive games Binocular |
Additional relevant MeSH terms:
|
Amblyopia Brain Diseases Central Nervous System Diseases Nervous System Diseases Vision Disorders |
Sensation Disorders Neurologic Manifestations Eye Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013