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Advanced Surface Ablation (ASA) vs Laser-Assisted In Situ Keratomileusis (LASIK)
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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 |
- Visual Acuity [ Time Frame: 1 day, 1W, 1M, 3M, 6M, 9M, 12M ]
| 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 |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00778570
| Contact: George Mintsioulis, MD | 613-737-8926 | gmintsioulis@ottawahospital.on.ca | |
| Contact: W.Bruce Jackson, MD | 613-737-8759 | bjackson@ohri.ca |
| 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 | |
| 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 |
Additional relevant MeSH terms:
|
Astigmatism Myopia Hyperopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on June 23, 2017