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NCT00778570 Clinical Trial

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

Astigmatism Clinical Trial

Official title:
A Combined Retrospective and Prospective Chart Review Analysis of Visual Outcomes Following Excimer Laser Vision Correction

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00778570
Other study ID # 2006800-01H
Secondary ID
Status Recruiting
Phase N/A
First received October 21, 2008
Last updated November 28, 2014
Start date February 2007
Est. completion date December 2020

Study information
Verified date November 2014
Source Ottawa Hospital Research Institute
Contact George Mintsioulis, MD
Phone 613-737-8926
Email gmintsioulis@ottawahospital.on.ca
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 4000
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
Canada University of Ottawa Eye Institute Ottawa Ontario

Sponsors (1)
Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Acuity 1 day, 1W, 1M, 3M, 6M, 9M, 12M No
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