Comparison of Three Corneal Horizontal Marking Techniques Using iTrace™

October 23, 2013 updated by: Yonsei University
Before astigmatism reducing surgery, accurate corneal horizontal marking before surgery is important. Due to new corneal topographic method, iTrace™ surgical workstation, precise evaluation of corneal horizontal marking is available. In this study the investigators compared three known corneal horizontal making techniques and evaluate accuracy of each methods using iTrace™.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

156

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 102-752
        • Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine

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

50 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Who visited professor Tae Im Kim's clinic, department of ophthalmology, Severance hospital.

Description

Inclusion Criteria:

  • Patients who were scheduled to have cataract surgery
  • Age between 50 to 85 years

Exclusion Criteria:

  • With an underlying corneal or conjunctival disorder

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Group 1
Group 1 : Bare eye marking group
Group 2
Group 2 : Pendulum attached marker group
Group 3
Group 3 : Horizontal slit beam assisted marker group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The vertical height deviation and rotational axis misalignment amount of each three marking techniques, evaluated by iTrace surgical workstation.
Time Frame: Within 10 minutes after corneal horizontal marking.
Nasal and temporal marked spots saved in iTrace surgical workstation program.
Within 10 minutes after corneal horizontal marking.

Collaborators and Investigators

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

Sponsor

Yonsei University

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

October 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimate)

October 30, 2013

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1-2013-0049

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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