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Clinical Trials/TCTR20180523003
TCTR20180523003
Completed
Phase 3

Effectiveness of the Smartphone Application in Increasing Compliance to Occlusion Therapy in Children with Amblyopia: A Randomized Controlled Trial

Ratchadapiseksompotch Fund0 sites45 target enrollmentMay 23, 2018
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ConditionsAmblyopiaAmblyopia, Occlusion therapy, Compliance, Application, Randomized controlled trial

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Amblyopia
Sponsor
Ratchadapiseksompotch Fund
Enrollment
45
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

We developed the ATCU application with the intent to increase adherence to occlusion therapy. Our application significantly improves the percentage of compliance at 1-month and the BCVA at 1 and 3-month follow-up with positive feedback.

Registry
who.int
Start Date
May 23, 2018
End Date
December 30, 2019
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Ratchadapiseksompotch Fund

Eligibility Criteria

Inclusion Criteria

  • •Inclusion criteria
  • •1\. Children aged 4\-12 years who have been diagnosed with unilateral strabismic, anisometropic, deprivation, or mixed type amblyopia in King Chulalongkorn Memorial Hospital and Rutnin Eye Hospital
  • •2\. Best\-corrected visual acuity in the amblyopic eye between 20/40 and 20/400
  • •3\. At least 2 lines difference in visual acuity between both eyes
  • •4\. No previous treatment of amblyopia other than spectacles and occlusion therapy
  • •5\. Refractive error correction for a minimum of 4 weeks
  • •6\. Parents or caregivers have their own smart phone or tablet that is compatible with either iOS or android operating system
  • •7\. The same parents or caregivers, along with the child, are able to make a follow up visit at each appointment during the study

Exclusion Criteria

  • •Exclusion criteria
  • •1\. Previous treatment for amblyopia other than spectacles and occlusion therapy
  • •2\. Presence of moderate to severe mental retardation or learning disability
  • •3\. Refractive error correction less than 4 weeks prior

Outcomes

Primary Outcomes

Not specified

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