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

Phase 3
Completed
Conditions
Amblyopia
Amblyopia, Occlusion therapy, Compliance, Application, Randomized controlled trial
Registration Number
TCTR20180523003
Lead Sponsor
Ratchadapiseksompotch Fund
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
45
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Objective compliance of occlusion therapy First month and third month follow up A percentage of actual patching hours to prescribed patching hours
Secondary Outcome Measures
NameTimeMethod
best corrected visual acuity 1 month and 3 months measured with the Snellen optotype and scored in logMAR unit
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