Patching or Gaming as Amblyopia Treatment?

NCT03767985 | Unknown

• 1 other identifier: MEC-2016-439
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

• Visual Acuity improvement

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

  24 weeks

Study Arms (2)

Occlusion therapy

ACTIVE COMPARATOR

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

Other: Occlusion therapy

Dichoptic video game therapy

EXPERIMENTAL

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

Other: Dichoptic video game therapy

Interventions

Dichoptic video game therapy OTHER

Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift.

Dichoptic video game therapy

Occlusion therapy OTHER

Occlusion therapy for 2 hours per day, 7 days a week

Occlusion therapy

Eligibility Criteria

• Age: 4 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Lijf & Leven: collaborator
• ODAS Stichting: collaborator
• Uitzicht: collaborator
• University of Applied Sciences Utrecht: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Related Publications (1)

• Tan ET, Kadhum A, Telleman MA, Treur A, Bruijning J, Loudon SE. How do parents experience patching or dichoptic action video gaming as amblyopia treatment? A qualitative study exploring treatment preferences and information needs to facilitate decision-making. Ophthalmic Physiol Opt. 2023 Jul;43(4):649-659. doi: 10.1111/opo.13132. Epub 2023 Apr 3.

  PMID: 37010918 DERIVED

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

• Johannes R Vingerling, MD, PhD

  Erasmus Medical Center

  STUDY DIRECTOR

Central Study Contacts

Sjoukje E Loudon, MD, PhD

CONTACT

+31(0)624927128; s.loudon@erasmusmc.nl

Aveen Kadhum, Bsc

CONTACT

+31 (0)10 7032103; a.kadhum@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The research orthoptist that does the orthoptic examinations is masked to the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Participants are randomized to either the standard patching therapy or the dichoptic video game therapy.

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 7, 2018
• Study Start: December 18, 2017
• Primary Completion: June 24, 2020
• Study Completion: December 31, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

NL (1)