NCT01308307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
Last Updated

March 8, 2011

Status Verified

October 1, 2009

First QC Date

March 3, 2011

Last Update Submit

March 7, 2011

Conditions

Amblyopia

Keywords

Non-cycloplegic photorefractioncycloplegic refraction,Amblyopia

Outcome Measures

Primary Outcomes (1)

  • refraction

    cycloplegic auto refraction \& Non-cycloplegic photorefraction

    10 months

Secondary Outcomes (1)

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

    10 months

Study Arms (1)

one arm

EXPERIMENTAL
Device: photorefraction

Interventions

photorefractionDEVICE

photorefraction is a name of device.

one arm

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \> 1 year old /with consent

You may not qualify if:

  • mental retardation
  • impaired fixation
  • strabismus
  • ptosis and any other organic ophthalmic disorder interfering with refraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Labbafinejad medical center

Tehran, Iran

Location

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2011

First Posted

March 4, 2011

Study Start

October 1, 2009

Study Completion

August 1, 2010

Last Updated

March 8, 2011

Record last verified: 2009-10

Locations

IR(1)