Binocularly Balanced Viewing Study

NCT03754153 | Completed DMC

• 1 other identifier: DALA1031
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Other: Standard Therapy - Occlusion (patching) or blurring (atropine)

Interventions

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).

Balanced Binocular Viewing (BBV)

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

Standard Therapy - Occlusion (patching) or blurring (atropine)

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39079927 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.

  PMID: 35613759 DERIVED

MeSH Terms

Conditions

Amblyopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Annegret Dahlmann-Noor

  Moorfields Eye Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: At each site, a masked orthoptist will carry out the study assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-group parallel randomized controlled trial

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: November 27, 2018
• Study Start: October 28, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Will be made available after publication of the trial findings.
• Access Criteria: As per review by sponsor and principal investigator.

Locations

GB (1)