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

November 28, 2014 updated by: Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • University of Ottawa Eye Institute
        • Contact:
        • Principal Investigator:
          • George Minstioulis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity
Time Frame: 1 day, 1W, 1M, 3M, 6M, 9M, 12M
1 day, 1W, 1M, 3M, 6M, 9M, 12M

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: George Mintsioulis, MD, University of Ottawa Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 21, 2008

First Submitted That Met QC Criteria

October 21, 2008

First Posted (Estimate)

October 23, 2008

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 28, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006800-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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