NCT01183702

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

8.8 years

First QC Date

August 13, 2010

Last Update Submit

January 11, 2017

Conditions

Laser Corneal Surgery

Keywords

LASIK vs. non-LASIK

Outcome Measures

Primary Outcomes (1)

  • Corneal hydration (swelling)

    Two hours

Study Arms (2)

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

LASIK surgeryPROCEDURE

Participants have received LASIK surgery and their eyes are healthy.

Also known as: Refractive Surgery
LASIK
No InterventionOTHER

Participant has healthy eyes not altered by LASIK surgery.

Also known as: Normal cornea, no refractive surgery
non-LASIK

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Department (Gowdy Field Building, 5th Floor)

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Interventions

Refractive Surgical Procedures

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Deborah M Grzybowski, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Research Professor

Study Record Dates

First Submitted

August 13, 2010

First Posted

August 18, 2010

Study Start

February 1, 2004

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

US(1)