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

NCT05620173 | Active Not Recruiting

• 1 other identifier: NL79107.000.22
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

Amblyopia, Anisometropic; Amblyopia Strabismic; Amblyopia

Keywords

RCT; children; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Treatment adherence to the VAT defined as time played per day

  Daily registration of time played up to week 16

• Rate of change in visual acuity outcomes

  Each clinical visit (approximately 1 month)

Other Outcomes (6)

• Change on Disease specific quality of life measured with the CAT-QoL

  Baseline and at crossover (16 weeks after baseline)

• 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

• Change in stereopsis measured in seconds of arch

  Each clinical visit (approximately 1 month)

Study Arms (2)

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.

Device: Vedea Amblyopia Therapy (VAT)

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.

Device: Vedea Amblyopia Therapy (VAT); Device: Occlusion therapy

Interventions

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 then Vedea Amblyopia Therapy (VAT); Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy

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.

Also known as: Patching

Occlusion therapy then Vedea Amblyopia Therapy (VAT)

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vedea Healthware BV: lead
• Health Holland: collaborator
• Oogziekenhuis Rotterdam: collaborator
• Rotterdams Oogheelkundig Instituut: collaborator
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• Jeroen Bosch Ziekenhuis: collaborator

Study Sites (2)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

Location

The Rotterdam Eye Hospital

Rotterdam, South Holland, 3011 BH, Netherlands

Location

Related Publications (25)

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MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

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

Study Officials

• Martha Tjon-Fo-Sang, PhD

  The Rotterdam Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 17, 2022
• Study Start: February 22, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)