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

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Amblyopia

Treatments: Device: photorefraction

Study type: Interventional

Funder types: Other

Identifiers

NCT01308307

8821

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 1 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 1 year old /with consent

Exclusion criteria

• mental retardation
• impaired fixation
• strabismus
• ptosis and any other organic ophthalmic disorder interfering with refraction

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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185 participants in 1 patient group

one arm

Experimental group

Treatment:

Device: photorefraction