Advanced Surface Ablation (ASA) vs Laser-Assisted In Situ Keratomileusis (LASIK) - Full Text View

Sponsored by:	Ottawa Health Research Institute
Information provided by:	Ottawa Health Research Institute
ClinicalTrials.gov Identifier:	NCT00778570

Purpose

The purpose of this combined retrospective and prospective chart review analysis is to investigate the safety, efficacy, and predictability obtained via Laser-Assisted In Situ Keratomileusis (LASIK) and Advanced Surface Ablation (ASA) over a wide range of refractive errors

The working hypothesis is that there will be no difference in clinical outcomes between patients treated with LASIK or ASA.

Condition
Nearsightedness Farsightedness Astigmatism

U.S. FDA Resources

Study Type:	Observational
Official Title:	A Combined Retrospective and Prospective Chart Review Analysis of Visual Outcomes Following Excimer Laser Vision Correction

Further study details as provided by Ottawa Health Research Institute:

Primary Outcome Measures:

Visual Acuity [ Time Frame: 1 day, 1W, 1M, 3M, 6M, 9M, 12M ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	4000
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2010

Groups/Cohorts
ASA Participants treated for Excimer laser vision correction using Advanced Surface Ablation (ASA).
LASIK Participants treated for Excimer laser vision correction using Laser-Assisted In Situ Keratomileusis (LASIK)

Detailed Description:

Excimer laser vision correction (LVC) is a widely used procedure to correct nearsightedness, farsightedness, and astigmatism by reshaping the surface of the eye (cornea). Laser-Assisted In Situ Keratomileusis (LASIK) and Advanced Surface Ablation (ASA) and are techniques currently used to prepare the cornea for Excimer LVC.

This review is intended to study whether LASIK is equal in visual outcome (null hypothesis), more effective (alternate hypothesis 1) or less effective (alternate hypothesis 2) than ASA in clinical outcome up to one year.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Male and female participants from the Ottawa/Gatineau region requesting laser vision correction to correct nearsightedness, farsightedness, and/or astigmatism.

Criteria

Inclusion Criteria:

Eyes that were treated for LASIK or ASA Excimer laser vision correction before December 1st 2006 and newly recruited eyes that qualify for LASIK or ASA Excimer laser vision correction may be enrolled in this study.

Exclusion Criteria:

There are no exclusion criteria; all patients that went forward with Excimer laser vision correction may be included.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778570

Contacts

Contact: George Mintsioulis, MD	613-737-8926	gmintsioulis@ottawahospital.on.ca
Contact: W.Bruce Jackson, MD	613-737-8759	bjackson@ohri.ca

Locations

Canada, Ontario
University of Ottawa Eye Institute	Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Gail Kayuk, BSc 613-737-8657 gkayuk@ottawahospital.on.ca
Principal Investigator: George Minstioulis, MD

Sponsors and Collaborators

Ottawa Health Research Institute

Investigators

Principal Investigator:

George Mintsioulis, MD

University of Ottawa Eye Institute

More Information

Responsible Party:	University of Ottawa Eye Institute ( Dr. George Mintsioulis, MD )
Study ID Numbers:	2006800-01H
Study First Received:	October 21, 2008
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00778570
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Hyperopia
Eye Diseases
Myopia
Refractive Errors
Astigmatism

ClinicalTrials.gov processed this record on January 14, 2009