Patching or Gaming as Amblyopia Treatment?

A Randomised Clinical Trial Objectively Comparing the Effect of Patching Therapy With Video Gaming for Amblyopia

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.

Study Overview

• Status: Recruiting
• Conditions: Amblyopia
• Intervention / Treatment: Other: Occlusion therapy; Other: Dichoptic video game therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sjoukje E Loudon, MD, PhD; Phone Number: +31(0)624927128; Email: s.loudon@erasmusmc.nl
• Study Contact Backup: Name: Aveen Kadhum, Bsc; Phone Number: +31 (0)10 7032103; Email: a.kadhum@erasmusmc.nl

Study Locations

• Netherlands
  • South-Holland
    • Rotterdam, South-Holland, Netherlands, 3015 GD
      • Recruiting
      • Erasmus Medical Center
      • Contact: Aveen Kadhum, Bsc; Phone Number: +31 (0)10 7032103; Email: a.kadhum@erasmusmc.nl
      • Contact: Emily T.C. Tan, Bsc; Phone Number: +31(0)650032078; Email: e.tan@erasmusmc.nl
      • Principal Investigator: Sjoukje E Loudon, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Occlusion therapy; Participants are prescribed 2 hours of occlusion therapy per day, 7 days a week.	Other: Occlusion therapy; Occlusion therapy for 2 hours per day, 7 days a week
Experimental: Dichoptic video game therapy; Participants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision.	Other: Dichoptic video game therapy; Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity improvement	Visual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming	24 weeks

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Lijf & Leven; ODAS Stichting; Uitzicht; University of Applied Sciences Utrecht
• Investigators: Study Director: Johannes R Vingerling, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Actual): June 24, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia
• Other Study ID Numbers: MEC-2016-439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No