NCT00778570

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

13.8 years

First QC Date

October 21, 2008

Last Update Submit

November 28, 2014

Conditions

NearsightednessFarsightednessAstigmatism

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

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

Study Arms (2)

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)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Eye Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

MyopiaHyperopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • George Mintsioulis, MD

    University of Ottawa Eye Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

George Mintsioulis, MD

CONTACT

613-737-8926gmintsioulis@ottawahospital.on.ca

W.Bruce Jackson, MD

CONTACT

613-737-8759bjackson@ohri.ca

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2008

First Posted

October 23, 2008

Study Start

February 1, 2007

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

CA(1)