Corneal Biomechanics With Hydration in Normal and LASIK Eyes | NCT01183702

Studies
Corneal Biomechanics With Hydration in Normal and LASIK Eyes

NCT01183702

Sponsor

Deb Grzybowski

Status

Completed

Last Update Posted

Jan 13, 2017Estimated

Enrollment

44Actual

Phase

Not Applicable

Conditions

Laser Corneal Surgery

Interventions

LASIK surgery
No Intervention

Countries

United States

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

Jan 2017

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

Feb 2004

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Aug 13, 2010

First Submission Date that Met QC Criteria

Aug 13, 2010

First Posted Date

Aug 18, 2010Estimated

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

Jan 11, 2017

Last Update Posted Date

Jan 13, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas.

Detailed Description

The research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas. Subjects' corneas will be swelled with warmed, humidified nitrogen using modified diving goggles to assess structural changes due to a two hour swelling period. Subjects will be examined prior to swelling by a registered ophthalmologist to ensure that the cornea is healthy enough to undergo the swelling procedure. Pre-swelling and post-swelling data will be compared for parameters such as elasticity, density, thickness, axial and tangential curvature, hydration, and intraocular pressure in the central, paracentral, and peripheral regions. Analysis of pre-swelling and post-swelling data will allow for a better understanding of the structural changes created by LASIK. In addition, this project will allow for a better understanding of how common fluctuations in hydration levels affect normal corneal parameters as given by common devices in both populations to allow for corrections for more accurate measurements.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-LASIK	Active Comparator	These participants have NOT had LASIK surgery.	Other: No Intervention
LASIK	Active Comparator	These participants have had LASIK surgery.	Procedure: LASIK surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LASIK surgery	Procedure	Participants have received LASIK surgery and their eyes are healthy.	LASIK

Measure	Description	Time Frame
Corneal hydration (swelling)		Two hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy cornea without LASIK surgery as determined by a registered ophthalmologist.
Healthy cornea with LASIK surgery as determined by a registered ophthalmologist.

Exclusion Criteria:

Children under 18.
Unhealthy cornea as determined by a registered ophthalmologist.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deborah M Grzybowski, PhD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmology Department (Gowdy Field Building, 5th Floor)		Columbus	Ohio	43212	United States

Intervention Browse Module

MeSH Terms

ID	Term
D054140	Refractive Surgical Procedures

Ancestor Terms

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

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