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Comparison of Three Corneal Horizontal Marking Techniques Using iTrace™

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. Identifier: NCT01972191
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : October 30, 2013
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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™.

Condition or disease
Corneal Horizontal Marking.

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Study Type : Observational
Actual Enrollment : 156 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : October 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Who visited professor Tae Im Kim's clinic, department of ophthalmology, Severance hospital.

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

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 identifier (NCT number): NCT01972191

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

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Responsible Party: Yonsei University Identifier: NCT01972191     History of Changes
Other Study ID Numbers: 1-2013-0049
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Yonsei University:
Toric marking, Corneal horizontal marking