Trial record 2 of 5 for:
I-BiT
I-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia (I-BiT)
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| ClinicalTrials.gov Identifier: NCT01702727 |
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Recruitment Status :
Completed
First Posted : October 8, 2012
Last Update Posted : November 22, 2016
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Sponsor:
Nottingham University Hospitals NHS Trust
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Amblyopia | Device: I-BiTTM game Device: Non-I-BiTTM game Device: I-BiTTM DVD | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 75 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (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'). |
| Study Start Date : | June 2012 |
| Actual Primary Completion Date : | November 2013 |
| Actual Study Completion Date : | November 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: I-BiTTM game
30 minutes intervention weekly for 6 weeks.
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Device: I-BiTTM game
30 minutes intervention weekly for 6 weeks. |
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Active Comparator: Non-I-BiTTM game
30 minutes intervention weekly for 6 weeks.
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Device: Non-I-BiTTM game
30 minutes intervention weekly for 6 weeks. |
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Experimental: I-BiTTM DVD
30 minutes intervention weekly for 6 weeks.
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Device: I-BiTTM DVD
30 minutes intervention weekly for 6 weeks. |
Primary Outcome Measures :
- Change from baseline in visual acuity [ Time Frame: 6 weeks ]
Secondary Outcome Measures :
- Change from baseline in visual acuity [ Time Frame: 10 weeks ]
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| Ages Eligible for Study: | 4 Years to 8 Years (Child) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702727
Locations
| United Kingdom | |
| Cambridge University Hospitals NHS Trust | |
| Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ | |
| Nottingham University Hospitals NHS Trust | |
| Nottingham, Nottinghamshire, United Kingdom, NG7 2UH | |
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
Wellcome Trust
Investigators
| Principal Investigator: | Alexander Foss, BA BMBCh MRCP MRCOphth FRC | Consultant Ophthalmologist |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nottingham University Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01702727 |
| Other Study ID Numbers: |
10OY006 |
| First Posted: | October 8, 2012 Key Record Dates |
| Last Update Posted: | November 22, 2016 |
| Last Verified: | November 2016 |
Keywords provided by Nottingham University Hospitals NHS Trust:
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Amblyopia I-BiT TM Interactive games Binocular |
Additional relevant MeSH terms:
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Amblyopia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vision Disorders Sensation Disorders Neurologic Manifestations Eye Diseases |