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
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- The change of visual acuity from baseline to week six post randomisation visit between the two arms in each group. [ Time Frame: 6 weeks ]
- Successful delivery and installation of equipment to patients' homes, and any reasons for failure [ Time Frame: 10 weeks ]
- 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 ]
- The time taken by the patients to use the equipment in their home (unsupervised) setting. [ Time Frame: 10 weeks ]
- The robustness of the equipment by measuring failure / breakage rate. [ Time Frame: 10 weeks ]
- Completeness of outcome measures will be assessed via the frequency of missing data. [ Time Frame: 10 weeks ]
- The recruitment rate and reasons for not taking part. [ Time Frame: 10 weeks ]
- The retention rate and reasons for drop out. [ Time Frame: 10 weeks ]
- Any problems encountered with the randomisation process. [ Time Frame: 10 weeks ]
- 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 ]
- 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 ]
- Change in stereoacuity from baseline to week 3 post randomisation between the two arms. [ Time Frame: 3 weeks ]
- Change in stereoacuity from week 3 to weeks 6 and 10 for the I-BiT treated groups. [ Time Frame: 8 Weeks ]
- 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 ]
- Change in binocular status and ocular alignment from week 6 to week 10 for the I-BiT treated groups. [ Time Frame: 5 weeks ]
- Quality of life questionnaire at week 6. [ Time Frame: 6 weeks ]
- 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 ]
- 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 ]
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
|Contact: Rebecca Brown||0115 9249924 ext 67150||Rebecca.firstname.lastname@example.org|
|Contact: Natalie McGregor, PhDemail@example.com|
|Principal Investigator:||Alexander JE Foss, DM FRCOphth MRCP||Nottingham University Hospitals NHS Trust|