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Patching or Gaming as Amblyopia Treatment?

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ClinicalTrials.gov Identifier: NCT03767985
Recruitment Status : Unknown
Verified December 2018 by Sjoukje Elizabeth Loudon, Erasmus Medical Center.
Recruitment status was:  Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborators:
Lijf & Leven
ODAS
Uitzicht
University of Applied Sciences Utrecht
Information provided by (Responsible Party):
Sjoukje Elizabeth Loudon, Erasmus Medical Center

Tracking Information
First Submitted Date  ICMJE December 6, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date December 7, 2018
Actual Study Start Date  ICMJE December 18, 2017
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
Visual Acuity improvement [ Time Frame: 24 weeks ]
Visual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patching or Gaming as Amblyopia Treatment?
Official Title  ICMJE A Randomised Clinical Trial Objectively Comparing the Effect of Patching Therapy With Video Gaming for Amblyopia
Brief Summary Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. Standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular to improve visual acuity not only in children but also in adults. In this study we aim to compare the standard occlusion therapy with dichoptic video gaming.
Detailed Description

Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. The standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular. The rationale behind these games is by using dichoptic stimulation, with the contrast of the stimuli presented to the good eye reduced to match the appearance of the same stimuli when shown to the amblyopic eye, suppression can be alleviated. The many studies now conducted, demonstrate improvement in visual acuity with the games, the effect however is limited, but the rate of improvement is higher. In these studies, prescribed patching-time was compared to realised game-time. We have demonstrated in multiple studies that electronically measured compliance is low: on average only 50%.

In this study we aim to compare the effect of patching therapy, using the ODM to objectively measure compliance, with the effect of a novel dichoptic action video game in children as well as in adults. In addition, the adult participants will undergo fMRI scans to document any changes in the visual cortex before and after either therapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are randomized to either the standard patching therapy or the dichoptic video game therapy.
Masking: Single (Care Provider)
Masking Description:
The research orthoptist that does the orthoptic examinations is masked to the randomization.
Primary Purpose: Treatment
Condition  ICMJE Amblyopia
Intervention  ICMJE
  • Other: Dichoptic video game therapy
    Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift.
  • Other: Occlusion therapy
    Occlusion therapy for 2 hours per day, 7 days a week
Study Arms  ICMJE
  • Active Comparator: Occlusion therapy
    Participants are prescribed 2 hours of occlusion therapy per day, 7 days a week.
    Intervention: Other: Occlusion therapy
  • Experimental: Dichoptic video game therapy
    Participants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision.
    Intervention: Other: Dichoptic video game therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Amblyopia; an interocular difference in visual acuity of at least 2 logMAR lines.

Exclusion Criteria:

  • A non-comitant or large angle constant strabismus >30Prism Dioptres, a neurological disorder, nystagmus, other eye disorders and diminished acuity due to medication, brain damage or trauma.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03767985
Other Study ID Numbers  ICMJE MEC-2016-439
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sjoukje Elizabeth Loudon, Erasmus Medical Center
Study Sponsor  ICMJE Erasmus Medical Center
Collaborators  ICMJE
  • Lijf & Leven
  • ODAS
  • Uitzicht
  • University of Applied Sciences Utrecht
Investigators  ICMJE
Study Director: Johannes R Vingerling, MD, PhD Erasmus Medical Center
PRS Account Erasmus Medical Center
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP