Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 185
- Locations
- 1
- Primary Endpoint
- refraction
Study Overview
Brief Summary
Purpose: : This study was performed to compare the accuracy of non-cycloplegic photorefraction with cycloplegic refraction in detection of refractive amblyopia risk factors and determine some corresponding beneficial cut points.
Method: In this diagnostic accuracy study, right eyes of 185 children (1 to 14 years) underwent first non-cycloplegic photorefraction (with PlusOptix SO4 photoscreener) and then cycloplegic refraction from October 2009 to August 2010. Based on the cycloplegic refraction results, hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D) were set as criteria based on AAPOS guidelines. The difference in detection of refractive amblyopia risk factors between the two methods was the main outcome measure.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •> 1 year old /with consent
Exclusion Criteria
- •mental retardation
- •impaired fixation
- •strabismus
- •ptosis and any other organic ophthalmic disorder interfering with refraction
Arms & Interventions
one arm
Intervention: photorefraction (Device)
Outcomes
Primary Outcomes
refraction
Time Frame: 10 months
cycloplegic auto refraction \& Non-cycloplegic photorefraction
Secondary Outcomes
- hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D) were set as criteria based on AAPOS guidelines.(10 months)