Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?
|ClinicalTrials.gov Identifier: NCT01308307|
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : March 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Amblyopia||Device: photorefraction||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||185 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?|
|Study Start Date :||October 2009|
|Study Completion Date :||August 2010|
|Experimental: one arm||
photorefraction is a name of device.
- refraction [ Time Frame: 10 months ]cycloplegic auto refraction & Non-cycloplegic photorefraction
- hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D) were set as criteria based on AAPOS guidelines. [ Time Frame: 10 months ]cycloplegic auto refraction & Non-cycloplegic photorefraction
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308307
|Iran, Islamic Republic of|
|Labbafinejad medical center|
|Tehran, Iran, Islamic Republic of|