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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01702727
Recruitment Status : Completed
First Posted : October 8, 2012
Last Update Posted : November 22, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 Design

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
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in visual acuity [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in visual acuity [ Time Frame: 10 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

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
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01702727     History of Changes
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:
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