AmblyopiaBALANCENCT03754153
Binocularly Balanced Viewing Study
A study testing Balanced Binocular Viewing (BBV) and Standard Therapy - Occlusion (patching) or blurring (atropine) in people with Amblyopia, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Balanced Binocular Viewing (BBV) and Standard Therapy - Occlusion (patching) or blurring (atropine)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 3.0 and less than 8.0 years
- unilateral anisometropic, strabismic or combined mechanism amblyopia
- best-corrected crowded logMAR visual acuity (BCVA) in the amblyopic eye worse than 0.2logMar
- best corrected visual acuity in the better seeing eye 0.2 or better
- difference in best corrected visual acuity between the two eyes of 0.2 logMAR or more
- adapted to spectacles with no improvement in acuity in affected eye for two consecutive visits
- no previous treatment for amblyopia other than glasses
Who cannot join
- ocular cause for reduced visual acuity
- inability to co-operate with assessment tests
- other developmental disorders or learning or neurological disability that would impact on adherence to treatment
- photopic epilepsy
- myopia with spherical equivalent of greater than -6.00DS
- previous intraocular surgery
- inability to perform a crowded letter logMAR visual acuity test using a clinical trials standard testing method (ATS-HOTV protocol), either by naming or by matching letters
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
About this study
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
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.
Read the detailed description
"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.
- Conditions
- Amblyopia
- Being tested
- Balanced Binocular Viewing (BBV), Standard Therapy - Occlusion (patching) or blurring (atropine)
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Balanced Binocular Viewing (BBV) |
| 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. Receives: Other: Standard Therapy - Occlusion (patching) or blurring (atropine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start28 Oct 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group parallel randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Dahlmann-Noor, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754153
- Sponsor's protocol ID
- DALA1031
- Acronym
- BALANCE
- Status last verified
- Dec 2021
- First submitted
- 31 Jul 2017
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual-level data will be made available on request to the principal investigator.
Publications
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.
PubMed 39079927Dahlmann-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.
PubMed 35613759
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03754153
- Acronym / sponsor ID
- BALANCE / DALA1031
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-group parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Balanced Binocular Viewing (BBV) | Experimental | Device: 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. |
| Standard Therapy - Occlusion (patching) or blurring (atropine) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age between 3.0 and less than 8.0 years
- unilateral anisometropic, strabismic or combined mechanism amblyopia
- best-corrected crowded logMAR visual acuity (BCVA) in the amblyopic eye worse than 0.2logMar
- best corrected visual acuity in the better seeing eye 0.2 or better
- difference in best corrected visual acuity between the two eyes of 0.2 logMAR or more
Key exclusion criteria (7 listed)
- ocular cause for reduced visual acuity
- inability to co-operate with assessment tests
- other developmental disorders or learning or neurological disability that would impact on adherence to treatment
- photopic epilepsy
- myopia with spherical equivalent of greater than -6.00DS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Balanced Binocular Viewing (BBV) |
| 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 | Other | Standard Therapy - Occlusion (patching) or blurring (atropine) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Derived from this study: PubMed 39079927Dahlmann-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.
- Derived from this study: PubMed 35613759Dahlmann-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.
- Individual participant dataSharing planned: Yes. Individual-level data will be made available on request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annegret Dahlmann-Noor principal investigator
Moorfields Eye Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balanced Binocular Viewing (BBV) and Standard Therapy - Occlusion (patching) or blurring (atropine) in people with Amblyopia, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evaluation of safety of the experimental intervention (time frame: 16 weeks from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754153, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021; AzTrials last refreshed its copy on 27 Oct 2026.