Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 20 for:    "Amblyopia" | "Neurotransmitter Agents"

Binocularly Balanced Viewing Study (BALANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03754153
Recruitment Status : Not yet recruiting
First Posted : November 27, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Moorfields Eye Hospital NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Amblyopia Device: Balanced Binocular Viewing (BBV) Other: Standard Therapy - Occlusion (patching) or blurring (atropine) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Annegret Dahlmann-Noor 020 7566 2013 res-admin@moorfields.nhs.uk

Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Annegret Dahlmann-Noor Moorfields Eye Hospital NHS Foundation Trust

Layout table for additonal information
Responsible Party: Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03754153     History of Changes
Other Study ID Numbers: DALA1031
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Amblyopia
Neurotransmitter Agents
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Molecular Mechanisms of Pharmacological Action