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| Name | Class |
|---|---|
| Lijf & Leven | UNKNOWN |
| ODAS Stichting | UNKNOWN |
| Uitzicht | UNKNOWN |
| University of Applied Sciences Utrecht |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occlusion therapy | Active Comparator | Participants are prescribed 2 hours of occlusion therapy per day, 7 days a week. |
|
| Dichoptic video game therapy | Experimental | Participants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dichoptic video game therapy | Other | Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity improvement | Visual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sjoukje E Loudon, MD, PhD | Contact | +31(0)624927128 | s.loudon@erasmusmc.nl | |
| Aveen Kadhum, Bsc | Contact | +31 (0)10 7032103 | a.kadhum@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Johannes R Vingerling, MD, PhD | Erasmus Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38757545 | Derived | Kadhum A, Tan ETC, Wenner Y, Joosse MV, Loudon SE. Effectiveness of optical treatment in amblyopia and validation of measuring spectacle compliance with the ODM. Ophthalmic Physiol Opt. 2024 Jul;44(5):945-953. doi: 10.1111/opo.13322. Epub 2024 May 17. | |
| 37010918 | Derived | Tan ET, Kadhum A, Telleman MA, Treur A, Bruijning J, Loudon SE. How do parents experience patching or dichoptic action video gaming as amblyopia treatment? A qualitative study exploring treatment preferences and information needs to facilitate decision-making. Ophthalmic Physiol Opt. 2023 Jul;43(4):649-659. doi: 10.1111/opo.13132. Epub 2023 Apr 3. |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| OTHER |
Participants are randomized to either the standard patching therapy or the dichoptic video game therapy.
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The research orthoptist that does the orthoptic examinations is masked to the randomization.
| Occlusion therapy | Other | Occlusion therapy for 2 hours per day, 7 days a week |
|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |