search
Back to results

Patching or Gaming as Amblyopia Treatment?

Primary Purpose

Amblyopia

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Dichoptic video game therapy
Occlusion therapy
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia

Eligibility Criteria

4 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Amblyopia; an interocular difference in visual acuity of at least 2 logMAR lines.

Exclusion Criteria:

  • A non-comitant or large angle constant strabismus >30Prism Dioptres, a neurological disorder, nystagmus, other eye disorders and diminished acuity due to medication, brain damage or trauma.

Sites / Locations

  • Erasmus Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Occlusion therapy

Dichoptic video game therapy

Arm Description

Participants are prescribed 2 hours of occlusion therapy per day, 7 days a week.

Participants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision.

Outcomes

Primary Outcome Measures

Visual Acuity improvement
Visual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming

Secondary Outcome Measures

Full Information

First Posted
December 6, 2018
Last Updated
August 20, 2021
Sponsor
Erasmus Medical Center
Collaborators
Lijf & Leven, ODAS Stichting, Uitzicht, University of Applied Sciences Utrecht
search

1. Study Identification

Unique Protocol Identification Number
NCT03767985
Brief Title
Patching or Gaming as Amblyopia Treatment?
Official Title
A Randomised Clinical Trial Objectively Comparing the Effect of Patching Therapy With Video Gaming for Amblyopia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
June 24, 2020 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Lijf & Leven, ODAS Stichting, Uitzicht, University of Applied Sciences Utrecht

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
Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. Standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular to improve visual acuity not only in children but also in adults. In this study we aim to compare the standard occlusion therapy with dichoptic video gaming.
Detailed Description
Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. The standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular. The rationale behind these games is by using dichoptic stimulation, with the contrast of the stimuli presented to the good eye reduced to match the appearance of the same stimuli when shown to the amblyopic eye, suppression can be alleviated. The many studies now conducted, demonstrate improvement in visual acuity with the games, the effect however is limited, but the rate of improvement is higher. In these studies, prescribed patching-time was compared to realised game-time. We have demonstrated in multiple studies that electronically measured compliance is low: on average only 50%. In this study we aim to compare the effect of patching therapy, using the ODM to objectively measure compliance, with the effect of a novel dichoptic action video game in children as well as in adults. In addition, the adult participants will undergo fMRI scans to document any changes in the visual cortex before and after either therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to either the standard patching therapy or the dichoptic video game therapy.
Masking
Care Provider
Masking Description
The research orthoptist that does the orthoptic examinations is masked to the randomization.
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Occlusion therapy
Arm Type
Active Comparator
Arm Description
Participants are prescribed 2 hours of occlusion therapy per day, 7 days a week.
Arm Title
Dichoptic video game therapy
Arm Type
Experimental
Arm Description
Participants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision.
Intervention Type
Other
Intervention Name(s)
Dichoptic video game therapy
Intervention Description
Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift.
Intervention Type
Other
Intervention Name(s)
Occlusion therapy
Intervention Description
Occlusion therapy for 2 hours per day, 7 days a week
Primary Outcome Measure Information:
Title
Visual Acuity improvement
Description
Visual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Amblyopia; an interocular difference in visual acuity of at least 2 logMAR lines. Exclusion Criteria: A non-comitant or large angle constant strabismus >30Prism Dioptres, a neurological disorder, nystagmus, other eye disorders and diminished acuity due to medication, brain damage or trauma.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sjoukje E Loudon, MD, PhD
Phone
+31(0)624927128
Email
s.loudon@erasmusmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Aveen Kadhum, Bsc
Phone
+31 (0)10 7032103
Email
a.kadhum@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes R Vingerling, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
South-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aveen Kadhum, Bsc
Phone
+31 (0)10 7032103
Email
a.kadhum@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Emily T.C. Tan, Bsc
Phone
+31(0)650032078
Email
e.tan@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Sjoukje E Loudon, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Patching or Gaming as Amblyopia Treatment?

We'll reach out to this number within 24 hrs