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
|Condition or disease||Intervention/treatment||Phase|
|Amblyopia||Other: Dichoptic video game therapy Other: Occlusion therapy||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|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.|
|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|
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.
- 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
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
|Contact: Sjoukje E Loudon, MD, PhD||+31(0)firstname.lastname@example.org|
|Contact: Aveen Kadhum, Bsc||+31 (0)10 email@example.com|
|Erasmus Medical Center||Recruiting|
|Rotterdam, South-Holland, Netherlands, 3015 GD|
|Contact: Aveen Kadhum, Bsc +31 (0)10 7032103 firstname.lastname@example.org|
|Contact: Emily T.C. Tan, Bsc +31(0)650032078 email@example.com|
|Principal Investigator: Sjoukje E Loudon, MD, PhD|
|Study Director:||Johannes R Vingerling, MD, PhD||Erasmus Medical Center|