Amblyopia, Anisometropic, Amblyopia Strabismic, Amblyopia
Conditions
Keywords
RCT, children, Virtual Reality
Brief summary
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.
Interventions
DEVICEVedea Amblyopia Therapy (VAT)
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.
DEVICEOcclusion therapy
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.
Sponsors
Health Holland
Oogziekenhuis Rotterdam
Rotterdams Oogheelkundig Instituut
Elisabeth-TweeSteden Ziekenhuis
Jeroen Bosch Ziekenhuis
Vedea Healthware BV
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* wearing the full corrected refraction for ≥14 weeks to adapt to the glasses * diagnosed with an unilateral anisometropic, strabismic and/or deprivation amblyopia. 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). * currently under treatment or starting treatment for unilateral amblyopia * participants must have easy access to an Android device equal to or higher than a Samsung Galaxy S8 * written informed consent by parents or legal guardians
Exclusion criteria
* current treatment with atropine penalisation * documented history of severe negative side effects that occur with exposure to VR usage (eg. seizures or epileptic spasms) * photosensitivity * no developmental delay * coexisting ocular pathology or systemic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Visual Acuity measured in LogMAR lines | Each clinical visit (approximately 1 month) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment adherence to the VAT defined as time played per day | Daily registration of time played up to week 16 | Adherence will be calculated using the following framework: * 30 minutes per day = excellent treatment adherence * 20-29 minutes per day = good treatment adherence * 15-19 minutes per day = average treatment adherence ≤ 14 minutes per day = bad treatment adherence |
| Rate of change in visual acuity outcomes | Each clinical visit (approximately 1 month) | Rate of change is defined as the number of weeks it takes to reach the highest visual acuity score. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in the prism cover test using angle of deviation | Each clinical visit (approximately 1 month) | 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. |
| Change on Disease specific quality of life measured with the CAT-QoL | Baseline and at crossover (16 weeks after baseline) | 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. |
| Diplopia using a standardized questionnaire | Each clinical visit (approximately 1 month) | The questionnaire is administered to the participants and their parents to assess the presence and frequency of diplopia |
| Change in suppression/fusion measured in degrees | Each clinical visit (approximately 1 month) | — |
| System Usability using the System Usability Scale (SUS) | At crossover (after 16 weeks) for the experimental group and at the end of crossover (after 32 weeks) for the active comparator group | 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. |
| Change in stereopsis measured in seconds of arch | Each clinical visit (approximately 1 month) | Stereopsis is calculated by taking the least difference in seconds of arc that the individual can perceive binocularly. |
Countries
Netherlands
Outcome results
None listed