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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01308307
First Posted: March 4, 2011
Last Update Posted: March 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose

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 Intervention Phase
Amblyopia Device: photorefraction Phase 2

Study Type: Interventional
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • refraction [ Time Frame: 10 months ]
    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. [ Time Frame: 10 months ]
    cycloplegic auto refraction & Non-cycloplegic photorefraction


Enrollment: 185
Study Start Date: October 2009
Study Completion Date: August 2010
Arms Assigned Interventions
Experimental: one arm Device: photorefraction
photorefraction is a name of device.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308307


Locations
Iran, Islamic Republic of
Labbafinejad medical center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
  More Information

Responsible Party: Zhale Rajavi, Ophthalmic Research center
ClinicalTrials.gov Identifier: NCT01308307     History of Changes
Other Study ID Numbers: 8821
First Submitted: March 3, 2011
First Posted: March 4, 2011
Last Update Posted: March 8, 2011
Last Verified: October 2009

Keywords provided by Shahid Beheshti University of Medical Sciences:
Non-cycloplegic photorefraction
cycloplegic refraction,
Amblyopia

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms