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Active, Not Recruiting

NCT Number: NCT05620173

Validation of New Virtual Reality Treatment for Children With Lazy Eye Using the 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Amblyopia, Anisometropic Amblyopia Amblyopia Strabismic Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, North Brabant, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Patching

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Change in suppression/fusion measured in degrees

    Time frame: Each clinical visit (approximately 1 month)

  6. 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

Sponsors and collaborators

Lead sponsor

Vedea Healthware BV

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: VAT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2022
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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