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

NCT ID: NCT00778570

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nearsightedness Farsightedness Astigmatism

Study Groups

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ASA

Participants treated for Excimer laser vision correction using Advanced Surface Ablation (ASA).

No interventions assigned to this group

LASIK

Participants treated for Excimer laser vision correction using Laser-Assisted In Situ Keratomileusis (LASIK)

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Mintsioulis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa Eye Institute

Locations

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University of Ottawa Eye Institute

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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George Mintsioulis, MD

Role: CONTACT

613-737-8926

W.Bruce Jackson, MD

Role: CONTACT

613-737-8759

Facility Contacts

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Gail Kayuk, BSc

Role: primary

613-737-8657

Other Identifiers

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2006800-01H

Identifier Type: -

Identifier Source: org_study_id