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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT01308307
Study type Interventional
Source hahid Beheshti University of Medical Sciences
Contact
Status Completed
Phase Phase 2
Start date October 2009
Completion date August 2010

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