Validation of New Virtual Reality Treatment for Children With Lazy Eye Using the Vedea Amblyopia Therapy (VAT)

Sponsor

Vedea Healthware BV (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05620173

Collaborator

Health Holland (Other), Oogziekenhuis Rotterdam (Other), Rotterdams Oogheelkundig Instituut (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amblyopia, Anisometropic Amblyopia Strabismic Amblyopia	Device: Vedea Amblyopia Therapy (VAT) Device: Occlusion therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

'Validation and Development of New Dichoptic VR-gaming Method to Treat Childhood Amblyopia; Vedea Amblyopia Therapy (VAT)

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy 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.	Device: Vedea 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.
Active Comparator: Occlusion therapy then Vedea Amblyopia Therapy (VAT) 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.	Device: Vedea 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. Device: Occlusion 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. Other Names: Patching

Arm

Intervention/Treatment

Experimental: Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy

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.

Device: Vedea 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.

Active Comparator: Occlusion therapy then Vedea Amblyopia Therapy (VAT)

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.

Device: Vedea 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.

Device: Occlusion 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.

Other Names:

Patching

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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.
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.
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 in suppression/fusion measured in degrees [Each clinical visit (approximately 1 month)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Vedea Healthware BV
Health Holland
Oogziekenhuis Rotterdam
Rotterdams Oogheelkundig Instituut

Investigators

Principal Investigator: Martha Tjon-Fo-Sang, PhD, The Rotterdam Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Vedea Healthware BV

ClinicalTrials.gov Identifier:

NCT05620173

Other Study ID Numbers:

NL79107.000.22

First Posted:

Nov 17, 2022

Last Update Posted:

Nov 17, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vedea Healthware BV

RCT

children

Virtual Reality

Additional relevant MeSH terms:

Amblyopia

Study Results

No Results Posted as of Nov 17, 2022