A Comparison of PRK and LASIK for Correction of Myopia

This study has been completed.

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00404105

Purpose

The study compares the precision and accuracy of two laser refractive techniques, PRK and LASIK, for correction of nearsightedness between -6 and -8 diopters.

Condition	Intervention	Phase
Myopia	Procedure: PRK Procedure: LASIK	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Prospective, Randomised Trial of Photo-Refractive Keratectomy (PRK) and Laser-in-Situ-Keratomileusis (LASIK) for Correction of Myopia

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Uncorrected visual acuity
Best corrected visual acuity
Best spectacle correction

Secondary Outcome Measures:

IOP
Corneal thickness
Corneal wavefront aberrations

Estimated Enrollment:	40
Study Start Date:	June 2000
Estimated Study Completion Date:	May 2004

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

spherical equivalent subjective refraction between -6.00 and -8.00 diopters
age between 18 and 49 years
desire for having laser refractive surgery

Exclusion Criteria:

present or past eye disease excluding myopia
pregnant or lactating woman

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404105

Locations

Denmark
Department of Ophthalmology, Aarhus Sygehus NBG
Aarhus C, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:

Jesper Hjortdal, MD, PhD

Department of Ophthalmology, Aarhus Sygehus, University of Aarhus

More Information

Study ID Numbers:	AUH-Ophthalmology-1999-01
Study First Received:	November 24, 2006
Last Updated:	November 24, 2006
ClinicalTrials.gov Identifier:	NCT00404105
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

Excimer laser

Study placed in the following topic categories:

Eye Diseases
Myopia
Refractive Errors

ClinicalTrials.gov processed this record on January 14, 2009