The Use of Interactive Binocular Treatment (I-BiT) for the Management of Anisometropic, Strabismi… (NCT02810847) | Clinical Trial Compass
UnknownNot Applicable
The Use of Interactive Binocular Treatment (I-BiT) for the Management of Anisometropic, Strabismic and Mixed Amblyopia in Children Aged 3.5 - 12 Years
182 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range
42 Months – 9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change of visual acuity from baseline to week six post randomisation visit between the two arms in each group.