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

March 7, 2024 updated by: Vedea Healthware BV

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Noord Brabant
      • 's-Hertogenbosch, Noord Brabant, Netherlands, 5223 GZ
        • Recruiting
        • Jeroen Bosch Ziekenhuis
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marianne Smeets
      • Tilburg, Noord Brabant, Netherlands, 5022GC
        • Recruiting
        • Elisabeth-TweeSteden Ziekenhuis
        • Contact:
        • Contact:
        • Principal Investigator:
          • Iemkje Donkers
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3011 BH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Visual Acuity measured in LogMAR lines
Time Frame: 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.
Each clinical visit (approximately 1 month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment adherence to the VAT defined as time played per day
Time Frame: 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
Daily registration of time played up to week 16
Rate of change in visual acuity outcomes
Time Frame: 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.
Each clinical visit (approximately 1 month)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Disease specific quality of life measured with the CAT-QoL
Time Frame: 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.
Baseline and at crossover (16 weeks after baseline)
System Usability using the System Usability Scale (SUS)
Time Frame: 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.
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
Time Frame: Each clinical visit (approximately 1 month)
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
Time Frame: 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.
Each clinical visit (approximately 1 month)
Change in suppression/fusion measured in degrees
Time Frame: Each clinical visit (approximately 1 month)
Each clinical visit (approximately 1 month)
Diplopia using a standardized questionnaire
Time Frame: Each clinical visit (approximately 1 month)
The questionnaire is administered to the participants and their parents to assess the presence and frequency of diplopia
Each clinical visit (approximately 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vedea Healthware BV

Collaborators

Elisabeth-TweeSteden Ziekenhuis
Jeroen Bosch Ziekenhuis
Health Holland
Oogziekenhuis Rotterdam
Rotterdams Oogheelkundig Instituut

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

November 10, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL79107.000.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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