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

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01308307
• Collaborator: (none)
• Enrollment: 185
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 18.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amblyopia	Device: photorefraction	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 185 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?
• Study Start Date: Oct 1, 2009
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: one arm	Device: photorefraction; photorefraction is a name of device.

Outcome Measures

Primary Outcome Measures

1. refraction [10 months]

   cycloplegic auto refraction & Non-cycloplegic photorefraction

Secondary Outcome Measures

1. hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D) were set as criteria based on AAPOS guidelines. [10 months]

   cycloplegic auto refraction & Non-cycloplegic photorefraction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 14 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Labbafinejad medical center	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01308307
• Other Study ID Numbers: 8821
• First Posted: Mar 4, 2011
• Last Update Posted: Mar 8, 2011
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: Non-cycloplegic photorefraction; cycloplegic refraction,; Amblyopia
• Additional relevant MeSH terms: Amblyopia

Study Results

No Results Posted as of Mar 8, 2011