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

Primary Purpose

Amblyopia

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
photorefraction
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amblyopia focused on measuring Non-cycloplegic photorefraction, cycloplegic refraction,, Amblyopia

Eligibility Criteria

1 Year - 14 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Labbafinejad medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one arm

Arm Description

Outcomes

Primary Outcome Measures

refraction
cycloplegic auto refraction & Non-cycloplegic photorefraction

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2011
Last Updated
March 7, 2011
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01308307
Brief Title
Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?
Official Title
Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
Non-cycloplegic photorefraction, cycloplegic refraction,, Amblyopia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
one arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
photorefraction
Intervention Description
photorefraction is a name of device.
Primary Outcome Measure Information:
Title
refraction
Description
cycloplegic auto refraction & Non-cycloplegic photorefraction
Time Frame
10 months
Secondary Outcome Measure Information:
Title
hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D) were set as criteria based on AAPOS guidelines.
Description
cycloplegic auto refraction & Non-cycloplegic photorefraction
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 1 year old /with consent Exclusion Criteria: mental retardation impaired fixation strabismus ptosis and any other organic ophthalmic disorder interfering with refraction
Facility Information:
Facility Name
Labbafinejad medical center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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