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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01308307
Enrollment
185
Registered
2011-03-04
Start date
2009-10-31
Completion date
2010-08-31
Last updated
2011-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia

Keywords

Non-cycloplegic photorefraction, cycloplegic refraction,, Amblyopia

Brief 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.

Interventions

DEVICEphotorefraction

photorefraction is a name of device.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* \> 1 year old /with consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
refraction10 monthscycloplegic auto refraction & Non-cycloplegic photorefraction

Secondary

MeasureTime frameDescription
hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D) were set as criteria based on AAPOS guidelines.10 monthscycloplegic auto refraction & Non-cycloplegic photorefraction

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026