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The Use of Interactive Binocular Treatment (I-BiT) for the Management of Anisometropic, Strabismic and Mixed Amblyopia in Children Aged 3.5 - 12 Years (I-BiT Plus)

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ClinicalTrials.gov Identifier: NCT02810847
Recruitment Status : Unknown
Verified June 2016 by Nottingham University Hospitals NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Wellcome Trust
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

Brief Summary:

Around one child in fifty has a lazy eye (termed amblyopia) where the eye is structurally normal but the vision fails to develop correctly. Around half of these children also have a squint (strabismus) where each eye has a different direction of gaze. This condition is the commonest cause of visual impairment in one eye in children.

This is a randomised control trial of wearing glasses alone (which will result in some visual improvement, termed refractive adaptation) and wearing glasses combined with using I-BiT Plus.

The hypothesis is that using I-BiT Plus will result in an improved visual outcome.


Condition or disease Intervention/treatment Phase
Amblyopia Strabismus Device: I-Bit plus Not Applicable

Detailed Description:

This study will treat amblyopia (lazy eye) using 3-D computer technology and active shutter glasses. Computer games and DVD's are viewed through the active shutter glasses and are specially prepared to preferentially stimulate the lazy eye; the child can only play the games accurately if they are using their lazy eye. The study is funded by the NIHR and will be undertaken as a randomised control trial to compare this against normal computer games and DVD viewing combined with continuing refractive adaptation (a process that is known to occur for up to 30 weeks). Patients will receive 6 weeks of treatment (recommended 30 mins minimum of play time per day for 6 weeks in the treatment arm) and level of vision will be assessed after 6 weeks and the visual improvement (they will be wearing glasses and also undergoing refractive adaptation) compared with the control. Patients will return to standard care after the trial period which, at 6 weeks, should not affect the final visual outcome in a negative way. The participants will be recruited from patients currently attending one of the 4 trial sites and will have a diagnosis of amblyopia, and be aged between 3 years 6 months and 9 years 11 months. Current treatments for amblyopia include wearing an eye patch over the good eye for up to 6 hours per day, or using eye drops to blur the image in the good eye for periods of 4 weeks at a time. The aim is both to avoid the need for patching or penalisation (which are unpopular treatments) and to get an improved visual outcome.

Assessment study: A study on 62 patients where the investigators will compare the visual acuity, angle of strabismus, stereoacuity and depth of suppression as estimated by I-BiT against measurements made at orthoptic assessment. This data will help interpret the results of the randomised controlled trial and help direct future development.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Interactive Binocular Treatment (I-BiT) for the Management of Anisometropic, Strabismic and Mixed Amblyopia in Children Aged 3.5 - 12 Years
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: I-BiT Plus
6 weeks of I-Bit treatment plus (at least 30 mins/day, 6 days/week)
Device: I-Bit plus
The study will treat amblyopia (lazy eye) using 3-D computer technology and active shutter glasses. Computer games and DVD's are viewed through the active shutter glasses and are specially prepared to preferentially stimulate the lazy eye; the child can only play the game accurately if they are using their lazy eye.

No Intervention: Control
Refractive adaption or observation



Primary Outcome Measures :
  1. The change of visual acuity from baseline to week six post randomisation visit between the two arms in each group. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Successful delivery and installation of equipment to patients' homes, and any reasons for failure [ Time Frame: 10 weeks ]
  2. The ability of the patients to use the equipment in their home (unsupervised) setting and any reasons why not. Ocular alignment Stereoacuity Proportion of patients completing course [ Time Frame: 10 weeks ]
  3. The time taken by the patients to use the equipment in their home (unsupervised) setting. [ Time Frame: 10 weeks ]
  4. The robustness of the equipment by measuring failure / breakage rate. [ Time Frame: 10 weeks ]
  5. Completeness of outcome measures will be assessed via the frequency of missing data. [ Time Frame: 10 weeks ]
  6. The recruitment rate and reasons for not taking part. [ Time Frame: 10 weeks ]
  7. The retention rate and reasons for drop out. [ Time Frame: 10 weeks ]
  8. Any problems encountered with the randomisation process. [ Time Frame: 10 weeks ]
  9. The standard deviation in visual acuity at 6 weeks; this will inform sample size calculations for a future trial to assess effectiveness of the I-BiT™ system. [ Time Frame: 6 weeks ]
  10. Change in visual acuity in the amblyopic eye from baseline to weeks 3 and 10 post randomisation between the two arms. [ Time Frame: 8 Weeks ]
  11. Change in stereoacuity from baseline to week 3 post randomisation between the two arms. [ Time Frame: 3 weeks ]
  12. Change in stereoacuity from week 3 to weeks 6 and 10 for the I-BiT treated groups. [ Time Frame: 8 Weeks ]
  13. Change in binocular status and ocular alignment from baseline to week 6 post randomisation between the two arms in each group. [ Time Frame: 6 Weeks ]
  14. Change in binocular status and ocular alignment from week 6 to week 10 for the I-BiT treated groups. [ Time Frame: 5 weeks ]
  15. Quality of life questionnaire at week 6. [ Time Frame: 6 weeks ]
  16. Proportion of patients completing course of treatment (defined as minimum of 18 hours in total, which equates to 30 minutes per day 6 days per week for six weeks). [ Time Frame: 18 hours ]
  17. The change in visual acuity, and angle of strabismus between weeks 3, 6 and 10 for the I-BiT treated groups. [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   42 Months to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The child must be aged between 3 years 6 months and 9 years 11 months (upper limit is one day before their 10th birthday on day of consent.)
  • Visual acuity difference of at least 0.3 log units, with the amblyopic eye being 0.3 logMAR or worse.
  • Must have undergone a minimum of 12 weeks refractive adaptation.
  • Those in group one must not have had patching or penalisation at all previously but the other two groups' participants may have had previous occlusion.
  • Must not have had previous strabismus surgery (for groups one and two, and for group three, they must start the treatment within 4 weeks of having surgery.
  • Must be able to use the I-BiT plus system.

Exclusion Criteria:

  • Stimulus deprivation amblyopia.
  • Other ocular or neurological disease affecting the visual system (including Down's syndrome, developmental delay,Craniofacial syndrome,Foetal Alcohol Syndrome, and cerebral palsy among other conditions).
  • Photosensitive epilepsy.
  • Parent, guardian or child not prepared to give consent.

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): NCT02810847


Contacts
Contact: Rebecca Brown 0115 9249924 ext 67150 Rebecca.brown4@nuh.nhs.uk
Contact: Natalie McGregor, PhD 01159709049 researchsponsor@nuh.nhs.uk

Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Wellcome Trust
Investigators
Principal Investigator: Alexander JE Foss, DM FRCOphth MRCP Nottingham University Hospitals NHS Trust

Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02810847     History of Changes
Other Study ID Numbers: 13OY006
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nottingham University Hospitals NHS Trust:
Amblyopia
strabismus
virtual reality
computer games

Additional relevant MeSH terms:
Amblyopia
Strabismus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases