Back to results

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

Primary Purpose

Nearsightedness, Farsightedness, Astigmatism

Status

Unknown status

Phase

Locations

Canada

Study Type

Observational

Intervention

About this trial

This is an observational trial for Nearsightedness

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Ottawa Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

ASA

LASIK

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual Acuity

Secondary Outcome Measures

Full Information

NCT ID

NCT00778570

First Posted

October 21, 2008

Last Updated

November 28, 2014

Sponsor

Ottawa Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00778570

Brief Title

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

Official Title

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

Study Type

Observational

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

February 2007 (undefined)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nearsightedness, Farsightedness, Astigmatism

7. Study Design

Enrollment

4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ASA

Arm Description

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

Arm Title

LASIK

Arm Description

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

Primary Outcome Measure Information:

Title

Visual Acuity

Time Frame

1 day, 1W, 1M, 3M, 6M, 9M, 12M

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Study Population Description

Male and female participants from the Ottawa/Gatineau region requesting laser vision correction to correct nearsightedness, farsightedness, and/or astigmatism.

Sampling Method

Non-Probability Sample

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

George Mintsioulis, MD

Phone

613-737-8926

gmintsioulis@ottawahospital.on.ca

First Name & Middle Initial & Last Name or Official Title & Degree

W.Bruce Jackson, MD

Phone

613-737-8759

bjackson@ohri.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George Mintsioulis, MD

Organizational Affiliation

University of Ottawa Eye Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Ottawa Eye Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gail Kayuk, BSc

Phone

613-737-8657

gkayuk@ottawahospital.on.ca

First Name & Middle Initial & Last Name & Degree

George Minstioulis, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs