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Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01308307
First Posted: March 4, 2011
Last Update Posted: March 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
March 3, 2011
March 4, 2011
March 8, 2011
October 2009
Not Provided
refraction [ Time Frame: 10 months ]
cycloplegic auto refraction & Non-cycloplegic photorefraction
Same as current
Complete list of historical versions of study NCT01308307 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?
Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Amblyopia
Device: photorefraction
photorefraction is a name of device.
Experimental: one arm
Intervention: Device: photorefraction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
August 2010
Not Provided

Inclusion Criteria:

  • > 1 year old /with consent

Exclusion Criteria:

  • mental retardation
  • impaired fixation
  • strabismus
  • ptosis and any other organic ophthalmic disorder interfering with refraction
Sexes Eligible for Study: All
1 Year to 14 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT01308307
8821
Not Provided
Not Provided
Not Provided
Zhale Rajavi, Ophthalmic Research center
Shahid Beheshti University of Medical Sciences
Not Provided
Not Provided
Shahid Beheshti University of Medical Sciences
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP