Binocularly Balanced Viewing Study (BALANCE)
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|ClinicalTrials.gov Identifier: NCT03754153|
Recruitment Status : Not yet recruiting
First Posted : November 27, 2018
Last Update Posted : November 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Amblyopia||Device: Balanced Binocular Viewing (BBV) Other: Standard Therapy - Occlusion (patching) or blurring (atropine)||Not Applicable|
"Lazy eye" (amblyopia) is the commonest sight problem in children, affecting about one in 30 children. It is caused by a difference in spectacle prescription between the eyes and/or a squint (eye misalignment), with the brain ignoring one eye. Amblyopia is treated by glasses and patches or blurring eyedrops to the good eye. This works in about 70% of children, but parents and children strongly dislike these treatments which may carry on for years and involve frequent clinic visits.
The Investigators have developed an exciting new treatment: children watch customized movies for an hour a day on a hand-held 3D computer-game console. The Investigators blur the picture that the good eye sees to match it with what the weaker eye sees. They have tested this approach on 22 children, with an average improvement in vision by three lines on the test chart over 8 - 24 weeks, which may be faster than with standard treatment. Parents and children the Investigators have spoken with like both the idea of research in this area and the engaging nature of this device. The Investigators now need to assess how the new treatment compares with standard treatment, but first need to ensure that the new treatment is safe and that families will use it.
In this pilot trial, 66 children will receive, at random, either a Nintendo 3DSXL console with movies, or standard patching/blurring eye-drop treatment. The Investigators will monitor adverse events (double vision), change in the balance between the two eyes and in visual acuity over 16 weeks. Parents and children have helped develop this pilot - this involvement will be continued throughout the study. At study completion, children and parents will be involved in deciding how best to communicate the findings on hospital websites, in newsletters, at conferences and in medical journals.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two-group parallel randomized controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||At each site, a masked orthoptist will carry out the study assessments.|
|Official Title:||Phase 2a Two-site Randomised Controlled Trial to Determine Safety of and Adherence With a New 'Binocularly Balanced Viewing' Treatment for Unilateral Amblyopia Compared With Standard Treatment in Children Age 3-8 Years|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||February 1, 2021|
Experimental: Balanced Binocular Viewing (BBV)
The experimental intervention will be BBV treatment, i.e. viewing movies for one hour or 2x30min/day on a Nintendo 3DSXL console. With this technology, the Investigators will show blurred images to the better-seeing eye and normal images to the amblyopic eye, encouraging the use of the amblyopic eye and improving acuity.
Device: Balanced Binocular Viewing (BBV)
The dose of BBV therapy will be one hour a day or 2x30 min/day (depending on child's attention span and/or need to implement the treatment around the family daily routine).
Active Comparator: Standard Therapy - Occlusion (patching) or blurring (atropine)
The control intervention will be either atropine eyedrops twice a week or daily occlusion (patching) therapy of the better-seeing eye (which are the current standards). As per clinical standard, parents will be offered the choice of occlusion or eyedrop treatment.
Other: Standard Therapy - Occlusion (patching) or blurring (atropine)
The prescribed dose of occlusion treatment / patching (parental choice) will depend on the severity of amblyopia, as by current clinical practice based on PEDIG studies
- The evaluation of safety of the experimental intervention [ Time Frame: 16 weeks from randomization ]To measure changes in suppression/interocular balance (considered to precede double vision) at 16 weeks from baseline, using a novel test of interocular balance, a contrast-sensitivity test presented on a PC
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): NCT03754153
|Contact: Annegret Dahlmann-Noor||020 7566 firstname.lastname@example.org|
|Principal Investigator:||Annegret Dahlmann-Noor||Moorfields Eye Hospital NHS Foundation Trust|