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CompletedNCT01308307Updated Mar 8, 2011

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

A Phase 2 interventional study of photorefraction in Amblyopia, sponsored by Shahid Beheshti University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 1 Year to 14 Years. Per ClinicalTrials.gov, last updated 2011-03-08.

Sponsored by Shahid Beheshti University of Medical Sciences · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
185
Allocation
Non-randomized
Ages
1 Year to 14 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Amblyopia

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Keywords

  • Non-cycloplegic photorefraction
  • cycloplegic refraction,
  • Amblyopia
03

In context

Amblyopia

183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.

This study's enrollment of 185 is above the median of 60 across 133 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 221 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • > 1 year old /with consent

Exclusion criteria

Exclusion Criteria:

  • mental retardation
  • impaired fixation
  • strabismus
  • ptosis and any other organic ophthalmic disorder interfering with refraction
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
Double (Care provider, Outcomes assessor)
Enrollment
185 participants (actual)

Study arms

  • Experimental
    one arm

    Device: photorefraction

Interventions

  • Devicephotorefraction

    photorefraction is a name of device.

06

What researchers measure

Primary outcomes

  1. refraction

    cycloplegic auto refraction \& Non-cycloplegic photorefraction

    Time frame: 10 months

Secondary outcomes

  1. 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

    Time frame: 10 months

07

Study locations

1 site
  • Labbafinejad medical center
    Tehran, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01308307
Lead sponsor
Shahid Beheshti University of Medical Sciences
First posted
Mar 4, 2011
Start date
Oct 2009
Completion
Aug 2010
Last update
Mar 8, 2011
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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