- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00350246
Long-term Effects of Laser Refractive Surgery
January 27, 2010 updated by: Mayo Clinic
This study will determine if there are short- and long-term postoperative differences in visual and corneal outcomes between different laser refractive surgical procedures.
Study Overview
Detailed Description
We will measure postoperative differences in visual acuity, contrast sensitivity, corneal light scatter, density of keratocytes and subbasal nerves, corneal sensitivity, corneal topography and wavefront between PRK performed with epithelial removal by a laser or by a rotary brush and between LASIK performed by using a microkeratome or by using a femtosecond laser.
Measurements will be made at baseline and at intervals over 5 postoperative years in 21 LASIK patients, 20 PRK patients, and 20 unoperated controls.
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Myopia 1-10 diopters No other ocular abnormalities except presbyopia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
keratocyte density at 5 years
|
nerve density at 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: William M. Bourne, M.D., Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Patel SV, McLaren JW, Kittleson KM, Bourne WM. Subbasal nerve density and corneal sensitivity after laser in situ keratomileusis: femtosecond laser vs mechanical microkeratome. Arch Ophthalmol. 2010 Nov;128(11):1413-9. doi: 10.1001/archophthalmol.2010.253.
- Calvo R, McLaren JW, Hodge DO, Bourne WM, Patel SV. Corneal aberrations and visual acuity after laser in situ keratomileusis: femtosecond laser versus mechanical microkeratome. Am J Ophthalmol. 2010 May;149(5):785-93. doi: 10.1016/j.ajo.2009.12.023. Epub 2010 Mar 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
July 7, 2006
First Submitted That Met QC Criteria
July 7, 2006
First Posted (Estimate)
July 10, 2006
Study Record Updates
Last Update Posted (Estimate)
January 28, 2010
Last Update Submitted That Met QC Criteria
January 27, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 66-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myopia
-
He Eye HospitalNot yet recruiting
-
University of BradfordCoopervision, Inc.; University of HuddersfieldNot yet recruiting
-
Visioneering Technologies, IncRecruitingMyopiaUnited States, Canada, Hong Kong, Singapore
-
University Eye Hospital, FreiburgRecruiting
-
Shanghai 10th People's HospitalCompletedMyopia | Myopia, ProgressiveChina
-
Tianjin Eye HospitalActive, not recruiting
-
Tianjin Eye HospitalCompleted
-
Sultan Qaboos UniversityChristian Medical College, Vellore, IndiaUnknown
-
Peking University People's HospitalUnknownProgressive MyopiaChina
-
Shanghai Eye Disease Prevention and Treatment CenterNot yet recruiting
Clinical Trials on Laser Refractive Surgery
-
Deb GrzybowskiCompleted
-
Second Affiliated Hospital of Nanchang UniversityActive, not recruitingRefractive Surgery | Visual QualityChina
-
Kasr El Aini HospitalRecruitingRefractive Errors | Myopia | Myopic AstigmatismEgypt
-
Tanta UniversityCompleted
-
Tanta UniversityUnknownMyopia | Perfusion; ComplicationsEgypt
-
Shahid Beheshti University of Medical SciencesCompleted
-
Kasr El Aini HospitalNot yet recruitingFS-LASIK Surgery Effect on Higher Order AberrationsEgypt
-
Wenzhou Medical UniversityCompleted
-
Vissum, Instituto Oftalmológico de AlicanteAarhus University Hospital; Centro Hospitalar e Universitário de Coimbra, E... and other collaboratorsRecruitingIndividualized Refractive SurgerySpain