The Lamina Cribrosa (LC) Changes in the Eyes After Laser-Assisted in Situ Keratomileusis (LASIK)

February 5, 2016 updated by: Changwon Kee, Samsung Medical Center

The Lamina Cribrosa (LC) Morphologic Changes in the Eyes After Laser-Assisted in Situ Keratomileusis (LASIK)

The burden of LASIK surgery on optic nerve head (ONH) has been controversial. Until now, the change of retinal nerve fiber layer (RNFL) thickness was used as the indicator of the study. In the present study, the investigators intended to investigate whether the changes of the deep and superficial structures around ONH exist or not using EDI OCT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The myopic patients who were supposed to undergo LASIK surgery

Description

Inclusion Criteria:

  • the myopic patients who were supposed to undergo LASIK surgery in the Samsung Medical Center

Exclusion Criteria:

  • Optic nerve head abnormalities at preoperative examination
  • Previous ocular surgical history

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
LASIK
Device: Exposed to the high pressure during the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of lamina cribrosa (LC) depth
Time Frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
micro millimeter
before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
Change of lamina cribrosa (LC) thickness
Time Frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
micro millimeter
before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
Change of optic nerve head (ONH) width
Time Frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
micro millimeter
before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of optic nerve head minimum rim width
Time Frame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
micro millimeter
before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

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, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • LASIK-LC study

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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