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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. 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.
"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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balanced Binocular Viewing (BBV) | Experimental | 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. |
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| Standard Therapy - Occlusion (patching) or blurring (atropine) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balanced Binocular Viewing (BBV) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The evaluation of safety of the experimental intervention | 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 | 16 weeks from randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annegret Dahlmann-Noor | Moorfields Eye Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moorfields Eye Hospital NHS Foundation Trust | London | EC1V 2PD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39079927 | Derived | Dahlmann-Noor AH, Greenwood JA, Skilton A, Baker D, Abbas M, Clay E, Khandelwal P, Dunham D, Ludden S, Davis A, Dehbi HM, Dakin SC. Feasibility of a new 'balanced binocular viewing' treatment for unilateral amblyopia in children aged 3-8 years (BALANCE): results of a phase 2a randomised controlled feasibility trial. BMJ Open. 2024 Jul 30;14(7):e082472. doi: 10.1136/bmjopen-2023-082472. | |
| 35613759 |
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Individual-level data will be made available on request to the principal investigator.
Will be made available after publication of the trial findings.
As per review by sponsor and principal investigator.
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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Two-group parallel randomized controlled trial
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At each site, a masked orthoptist will carry out the study assessments.
| Standard Therapy - Occlusion (patching) or blurring (atropine) | Other | 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 |
|
| Derived |
| Dahlmann-Noor AH, Greenwood JA, Skilton A, Baker D, Ludden S, Davis A, Dehbi HM, Dakin SC. Phase 2a randomised controlled feasibility trial of a new 'balanced binocular viewing' treatment for unilateral amblyopia in children age 3-8 years: trial protocol. BMJ Open. 2022 May 24;12(5):e051423. doi: 10.1136/bmjopen-2021-051423. |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |