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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

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.

Condition or disease Intervention/treatment Phase
Amblyopia Other: Dichoptic video game therapy Other: Occlusion therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
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
Official Title: A Randomised Clinical Trial Objectively Comparing the Effect of Patching Therapy With Video Gaming for Amblyopia
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Active Comparator: Occlusion therapy
Participants are prescribed 2 hours of occlusion therapy per day, 7 days a week.
Other: Occlusion therapy
Occlusion therapy for 2 hours per day, 7 days a week

Experimental: Dichoptic video game therapy
Participants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision.
Other: Dichoptic video game therapy
Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03767985


Contacts
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Contact: Sjoukje E Loudon, MD, PhD +31(0)624927128 s.loudon@erasmusmc.nl
Contact: Aveen Kadhum, Bsc +31 (0)10 7032103 a.kadhum@erasmusmc.nl

Locations
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Netherlands
Erasmus Medical Center Recruiting
Rotterdam, South-Holland, Netherlands, 3015 GD
Contact: Aveen Kadhum, Bsc    +31 (0)10 7032103    a.kadhum@erasmusmc.nl   
Contact: Emily T.C. Tan, Bsc    +31(0)650032078    e.tan@erasmusmc.nl   
Principal Investigator: Sjoukje E Loudon, MD, PhD         
Sponsors and Collaborators
Erasmus Medical Center
Lijf & Leven
ODAS
Uitzicht
University of Applied Sciences Utrecht
Investigators
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Study Director: Johannes R Vingerling, MD, PhD Erasmus Medical Center
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Responsible Party: Sjoukje Elizabeth Loudon, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03767985    
Other Study ID Numbers: MEC-2016-439
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases