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

Primary Purpose

Amblyopia, Anisometropic, Amblyopia Strabismic, Amblyopia

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Vedea Amblyopia Therapy (VAT)
Occlusion therapy
Sponsored by
Vedea Healthware BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia, Anisometropic focused on measuring RCT, children, Virtual Reality

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • The Rotterdam Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy

Occlusion therapy then Vedea Amblyopia Therapy (VAT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Treatment adherence to the VAT defined as time played per day
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
Rate of change is defined as the number of weeks it takes to reach the highest visual acuity score.

Full Information

First Posted
October 26, 2022
Last Updated
May 3, 2023
Sponsor
Vedea Healthware BV
Collaborators
Health Holland, Oogziekenhuis Rotterdam, Rotterdams Oogheelkundig Instituut
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1. Study Identification

Unique Protocol Identification Number
NCT05620173
Brief Title
Validation of New Virtual Reality Treatment for Children With Lazy Eye Using the Vedea Amblyopia Therapy (VAT)
Acronym
VAT
Official Title
'Validation and Development of New Dichoptic VR-gaming Method to Treat Childhood Amblyopia; Vedea Amblyopia Therapy (VAT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedea Healthware BV
Collaborators
Health Holland, Oogziekenhuis Rotterdam, Rotterdams Oogheelkundig Instituut

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia, Anisometropic, Amblyopia Strabismic, Amblyopia
Keywords
RCT, children, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Occlusion therapy then Vedea Amblyopia Therapy (VAT)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vedea Amblyopia Therapy (VAT)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Occlusion therapy
Other Intervention Name(s)
Patching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Visual Acuity measured in LogMAR lines
Description
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.
Time Frame
Each clinical visit (approximately 1 month)
Secondary Outcome Measure Information:
Title
Treatment adherence to the VAT defined as time played per day
Description
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
Time Frame
Daily registration of time played up to week 16
Title
Rate of change in visual acuity outcomes
Description
Rate of change is defined as the number of weeks it takes to reach the highest visual acuity score.
Time Frame
Each clinical visit (approximately 1 month)
Other Pre-specified Outcome Measures:
Title
Change on Disease specific quality of life measured with the CAT-QoL
Description
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.
Time Frame
Baseline and at crossover (16 weeks after baseline)
Title
System Usability using the System Usability Scale (SUS)
Description
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.
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
Title
Change in stereopsis measured in seconds of arch
Description
Stereopsis is calculated by taking the least difference in seconds of arc that the individual can perceive binocularly.
Time Frame
Each clinical visit (approximately 1 month)
Title
Change in the prism cover test using angle of deviation
Description
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.
Time Frame
Each clinical visit (approximately 1 month)
Title
Change in suppression/fusion measured in degrees
Time Frame
Each clinical visit (approximately 1 month)
Title
Diplopia using a standardized questionnaire
Description
The questionnaire is administered to the participants and their parents to assess the presence and frequency of diplopia
Time Frame
Each clinical visit (approximately 1 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teun Aalbers, PhD
Phone
+31621838699
Email
teun.aalbers@vedea.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Jansen
Phone
+31611763232
Email
daniel.jansen@vedea.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Tjon-Fo-Sang, PhD
Organizational Affiliation
The Rotterdam Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rotterdam Eye Hospital
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3011 BH
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Tjon-Fo-Sang, PhD
Phone
+31 (0)10 40 17 777
Email
M.Tjon@oogziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Susan Marinissen
Phone
+31 (0)10 40 23 449
Email
S.Marinissen@oogziekenhuis.nl

12. IPD Sharing Statement

Plan to Share IPD
No
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Validation of New Virtual Reality Treatment for Children With Lazy Eye Using the Vedea Amblyopia Therapy (VAT)

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