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

NCT ID: NCT01308307

Last Updated: 2011-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Amblyopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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one arm

Group Type EXPERIMENTAL

photorefraction

Intervention Type DEVICE

photorefraction is a name of device.

Interventions

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photorefraction

photorefraction is a name of device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* \> 1 year old /with consent

Exclusion Criteria

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

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ophthalmic Research center

Locations

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Labbafinejad medical center

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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8821

Identifier Type: -

Identifier Source: org_study_id

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