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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Ottawa Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00778570
First received: October 21, 2008
Last updated: November 28, 2014
Last verified: November 2014
History of Changes
  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

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 Hospital Research Institute:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 1 day, 1W, 1M, 3M, 6M, 9M, 12M ] [ Designated as safety issue: No ]
Estimated Enrollment: 4000
Study Start Date: February 2007
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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
Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Hospital Research Institute
Investigators
Principal Investigator: George Mintsioulis, MD University of Ottawa Eye Institute
  More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00778570     History of Changes
Other Study ID Numbers: 2006800-01H 
Study First Received: October 21, 2008
Last Updated: November 28, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Astigmatism
Myopia
Hyperopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on September 23, 2016