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Completed

NCT Number: NCT01702727

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

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.

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Key information

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cambridge University Hospitals NHS Trust, Cambridge, Cambridgeshire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-BiTTM game

Device

30 minutes intervention weekly for 6 weeks.

Non-I-BiTTM game

Device

30 minutes intervention weekly for 6 weeks.

I-BiTTM DVD

Device

30 minutes intervention weekly for 6 weeks.

Primary outcomes

  1. Change from baseline in visual acuity

    Time frame: 6 weeks

Secondary outcomes

  1. Change from baseline in visual acuity

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Collaborators

  • Wellcome Trust

Registry information

Official study 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').

Acronym: I-BiT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2012
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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