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| Name | Class |
|---|---|
| Health Holland | OTHER |
| Oogziekenhuis Rotterdam | OTHER |
| Rotterdams Oogheelkundig Instituut | UNKNOWN |
| Elisabeth-TweeSteden Ziekenhuis |
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The purpose of this clinical study is to validate the effectiveness of the Vedea Amblyopia Therapy (VAT) as a treatment for children with lazy eye.
The main question it aims to answer is to prove that the VAT is as effective or more effective than the current gold standard for treating children with lazy eye. This is occlusion therapy by patching the dominant eye.
Participants will play VR-games specifically designed for children with lazy eye for 30 minutes per day, 5 days per week for 16 weeks. This group of children will be compared to children that undergo regular occlusion therapy to see how both treatments options compare.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy | Experimental | Children in this intervention arm will use the VAT for 16 weeks. After the initial 16 weeks of treatment these children will be allowed to use the VAT for another 16 weeks. |
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| Occlusion therapy then Vedea Amblyopia Therapy (VAT) | Active Comparator | Children in this intervention arm will adhere to a 'care as usual' regimen consisting of occlusion therapy as prescribed by their health care provider. They will do so for 16 weeks. After the initial 16 weeks of treatment these children will crossover into the experimental arm to examine if they are still responsive to the VAT after already completing 16 weeks of traditional treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedea Amblyopia Therapy (VAT) | Device | Children will use the VAT for 5 days per week, 30 minutes per day. They play VR-games using a VR-headset, which content is optimized for dichoptic training. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Visual Acuity measured in LogMAR lines | The LogMAR method is a validated and often used method of measuring visual acuity in children (with or without amblyopia). Possible scores range from 0 (perfect vision) to 1.0 or higher as really bad vision. | Each clinical visit (approximately 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment adherence to the VAT defined as time played per day | Adherence will be calculated using the following framework:
| Daily registration of time played up to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change on Disease specific quality of life measured with the CAT-QoL | The CAT-QoL is a disease-specific health related quality of life (HRQoL) measure for amblyopia in children between 4 - 7 years of age. It has eight items (questions), which encompass physical, psychological and social aspects of daily life. Each item has three response levels. | Baseline and at crossover (16 weeks after baseline) |
Inclusion Criteria:
Amblyopia was defined as an intraocular difference (IOD) in visual acuity (VA) of 0.2 log MAR (2 lines) or more. Angle of strabismus ≤ 10 prism diopters at near and distance fixation. Current clear media (in case of deprivation amblyopia after successful surgery).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Tjon-Fo-Sang, PhD | The Rotterdam Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | North Brabant | 5223 GZ | Netherlands | ||
| The Rotterdam Eye Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15814192 | Background | Akizuki H, Uno A, Arai K, Morioka S, Ohyama S, Nishiike S, Tamura K, Takeda N. Effects of immersion in virtual reality on postural control. Neurosci Lett. 2005 Apr 29;379(1):23-6. doi: 10.1016/j.neulet.2004.12.041. Epub 2005 Jan 8. | |
| 23685164 | Background | Bailey IL, Lovie-Kitchin JE. Visual acuity testing. From the laboratory to the clinic. Vision Res. 2013 Sep 20;90:2-9. doi: 10.1016/j.visres.2013.05.004. Epub 2013 May 17. |
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| OTHER |
| Jeroen Bosch Ziekenhuis | OTHER |
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| Occlusion therapy | Device | Children are given an eye patch to occlude their dominant eye with for a prescribed number of hours per day. This may typically range anywhere between 2-8 hours per day, depending on the severity of the amblyopia. |
|
|
| Rate of change in visual acuity outcomes | Rate of change is defined as the number of weeks it takes to reach the highest visual acuity score. | Each clinical visit (approximately 1 month) |
| System Usability using the System Usability Scale (SUS) | The System Usability Scale (SUS) provides a reliable tool for measuring the usability of a system. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. | At crossover (after 16 weeks) for the experimental group and at the end of crossover (after 32 weeks) for the active comparator group |
| Change in stereopsis measured in seconds of arch | Stereopsis is calculated by taking the least difference in seconds of arc that the individual can perceive binocularly. | Each clinical visit (approximately 1 month) |
| Change in the prism cover test using angle of deviation | The prism cover test (PCT) is an objective measurement and the gold standard in measuring strabismus, i.e. ocular misalignment, or a deviation of the eye. It is used by ophthalmologists and orthoptists in order to measure the vertical and horizontal deviation. | Each clinical visit (approximately 1 month) |
| Change in suppression/fusion measured in degrees | Each clinical visit (approximately 1 month) |
| Diplopia using a standardized questionnaire | The questionnaire is administered to the participants and their parents to assess the presence and frequency of diplopia | Each clinical visit (approximately 1 month) |
| Rotterdam |
| South Holland |
| 3011 BH |
| Netherlands |
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| 28141763 | Background | Foss AJ. Use of video games for the treatment of amblyopia. Curr Opin Ophthalmol. 2017 May;28(3):276-281. doi: 10.1097/ICU.0000000000000358. |
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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 |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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