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

Amblyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308307
• Other study ID #: 8821
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2011
• Last updated: March 7, 2011
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: October 2009
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 14 Years

Eligibility

Inclusion Criteria:

• > 1 year old /with consent

Exclusion Criteria:

• mental retardation

• impaired fixation

• strabismus

• ptosis and any other organic ophthalmic disorder interfering with refraction

Study Design

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

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• photorefraction
photorefraction is a name of device.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Labbafinejad medical center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	refraction	cycloplegic auto refraction & Non-cycloplegic photorefraction	10 months
Secondary	hyperopia (=+3.5D), myopia (=-3D), astigmatism (=1.5D), and anisometropia (=1.5D) were set as criteria based on AAPOS guidelines.	cycloplegic auto refraction & Non-cycloplegic photorefraction	10 months