A Comprehensive Assessment of Anterior Corneal Power by Different Devices

April 28, 2012 updated by: Yifan Feng, Wenzhou Medical University

A Comprehensive Assessment of the Precision and Agreement of Anterior Corneal Power Measurements Obtained Using Different Devices

To comprehensively assess the precision and agreement of anterior corneal power measurements using 8 different devices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Volunteers with healthy corneas will be measured by different instruments to detect their anterior corneal power. Only the right eye of each subject was selected. Measurements were repeated in the second session scheduled 1 to 2 weeks later.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Wenzhou Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The present study's definitions of reproducibility, repeatability and agreement were based on those adopted by the British Standards Institute and the International Organization for Standardization.

Corneal curvature measurement provides crucial information for calculating intraocular lens power,screening and managing corneal refractive surgeries and corneal disease.

Volunteers with healthy corneas will be measured by different instruments to detect their anterior corneal power.Only the right eye of each subject was selected.Measurements were repeated in the second session scheduled 1 to 2 weeks later, at almost the same time as the first session, by the same examiner using the same protocol.

Description

Inclusion Criteria:

  • healthy cornea,
  • best corrected distance visual acuity (BCVA) equal to or better than 20/25,
  • willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

  • History of refractive surgery or any keratoplasty procedure,
  • use of contact lenses,
  • history of corneal dystrophies or degenerative diseases,
  • history of glaucoma or ocular hypertension,
  • significant subjective dry eye symptoms, Schirmer I test results of less than 5.0 mm, tear film break-up time shorter than 5 seconds and corneal fluorescein staining positive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Corneal power measurement
All recruited volunteers in present study, that underwent corneal power measurement with 8 different instruments
Device: Corneal power measurement
All subjects will be underwent a full ophthalmic examination including vision, auto- and subjective refraction, slit-lamp examination, non-contact tonometry, corneal power measurements with the 8 devices and fundus examination.
Other Names:
  • Tomey RC-5000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flat corneal power
Time Frame: 2 weeks
The intrasession repeatability and intersession reproducibility of flat corneal curvature measurements by using the 8 commercially available instruments.
2 weeks
Steep corneal power
Time Frame: 2 weeks
The intrasession repeatability and intersession reproducibility of Steep corneal curvature measurements by using the 8 commercially available instruments.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vector power J0
Time Frame: 2 weeks
The intrasession repeatability and intersession reproducibility of vector power J0 measurements by using the 8 commercially available instruments.
2 weeks
Vector power J45
Time Frame: 2 weeks
The intrasession repeatability and intersession reproducibility of vector power J45 measurements by using the 8 commercially available instruments.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Investigators

  • Principal Investigator: Yifang Feng, MD, Eye Hospital, Wenzhou Medical College, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

April 25, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 28, 2012

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YNKT201101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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