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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Nottingham University Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
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
  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').

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Nottingham University Hospitals NHS Trust

Additional 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
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
Eye Diseases
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Vision Disorders

ClinicalTrials.gov processed this record on October 29, 2014