NCT00404105

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2000

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
Last Updated

November 27, 2006

Status Verified

November 1, 2006

First QC Date

November 24, 2006

Last Update Submit

November 24, 2006

Conditions

Myopia

Keywords

Excimer laser

Outcome Measures

Primary Outcomes (3)

  • Uncorrected visual acuity

  • Best corrected visual acuity

  • Best spectacle correction

Secondary Outcomes (3)

  • IOP

  • Corneal thickness

  • Corneal wavefront aberrations

Interventions

PRKPROCEDURE
LASIKPROCEDURE

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • present or past eye disease excluding myopia
  • pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Aarhus Sygehus NBG

Aarhus C, 8000, Denmark

Location

Related Publications (1)

  • Ivarsen A, Hjortdal J. Seven-year changes in corneal power and aberrations after PRK or LASIK. Invest Ophthalmol Vis Sci. 2012 Sep 6;53(10):6011-6. doi: 10.1167/iovs.12-10208.

    PMID: 22879417DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Study Officials

  • Jesper Hjortdal, MD, PhD

    Department of Ophthalmology, Aarhus Sygehus, University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2006

First Posted

November 27, 2006

Study Start

June 1, 2000

Study Completion

May 1, 2004

Last Updated

November 27, 2006

Record last verified: 2006-11

Locations

DK(1)