A Comparison of PRK and LASIK for Correction of Myopia | NCT00404105

Studies
A Comparison of PRK and LASIK for Correction of Myopia

NCT00404105

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Nov 27, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Myopia

Interventions

PRK
LASIK

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2000

Primary Completion Date

Not provided

Completion Date

May 2004

First Submitted Date

Nov 24, 2006

First Submission Date that Met QC Criteria

Nov 24, 2006

First Posted Date

Nov 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2006

Last Update Posted Date

Nov 27, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uncorrected visual acuity
Best corrected visual acuity
Best spectacle correction

Secondary Outcomes

Measure	Description	Time Frame
IOP
Corneal thickness
Corneal wavefront aberrations

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jesper Hjortdal, MD, PhD	Department of Ophthalmology, Aarhus Sygehus, University of Aarhus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Aarhus Sygehus NBG		Aarhus C		8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22879417	Derived	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.

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D048988	Corneal Surgery, Laser
D053685	Laser Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Name	Type	Description	Arm Group Labels	Other Names
PRK	Procedure
LASIK	Procedure