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

This study has been completed.
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01308307
First received: March 3, 2011
Last updated: March 7, 2011
Last verified: October 2009
History of Changes
  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 Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?

Further study details as provided by Shaheed Beheshti Medical University:

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

Ages Eligible for Study:   1 Year to 14 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308307

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

No publications provided

Responsible Party: Zhale Rajavi, Ophthalmic Research center
ClinicalTrials.gov Identifier: NCT01308307     History of Changes
Other Study ID Numbers: 8821
Study First Received: March 3, 2011
Last Updated: March 7, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:
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

ClinicalTrials.gov processed this record on May 16, 2013