The Lamina Cribrosa (LC) Changes in the Eyes After Laser-... | NCT02676557

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

NCT02676557

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Feb 8, 2016Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

The Lamina Cribrosa and Optic Nerve Head Changes

Interventions

Exposed to the high pressure during the surgery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Aug 2014Actual

Completion Date

Mar 2015Actual

First Submitted Date

Oct 19, 2015

First Submission Date that Met QC Criteria

Feb 5, 2016

First Posted Date

Feb 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2016

Last Update Posted Date

Feb 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Label	Type	Description	Intervention Names
LASIK			Device: Exposed to the high pressure during the surgery

Name	Type	Description	Arm Group Labels	Other Names
Exposed to the high pressure during the surgery	Device		LASIK

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The myopic patients who were supposed to undergo LASIK surgery

Sampling Method

Non-Probability Sample