Wavefront-guided Photorefractive Keratectomy (PRK) Versus Wavefront-guided Lasik for Myopia
A Prospective Randomized Eye to Eye Comparison of Fellow Eyes Undergoing Lasik With the IntraLase(TM) FS Versus PRK
2 other identifiers
interventional
34
1 country
1
Brief Summary
A prospective comparison of eyes undergoing wavefront-guided LASIK in one eye and wavefront-guided PRK in their fellow eye for myopia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 2, 2010
CompletedFirst Posted
Study publicly available on registry
June 9, 2010
CompletedApril 11, 2022
April 1, 2022
1.4 years
June 2, 2010
April 3, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Improvement in uncorrected visual acuity
Baseline to one year
Changes in best spectacle corrected visual acuity
Baseline to one year
Changes in 25 and 5% low contrast acuity
baseline to one year
Secondary Outcomes (3)
Changes in quality of vision
baseline to one year
Comparison of dry eye signs and symptoms between LASIK and PRK
baseline to one year
Changes in higher order aberrations
Baseline to one year
Study Arms (2)
Wavefront-guided PRK
ACTIVE COMPARATORWavefront-guided PRK
Wavefront-guided LASIK
ACTIVE COMPARATORWavefront-guided LASIK
Interventions
One eye undergoes wavefront-guided PRK with the Visx S4 CustomVue excimer laser.
One eye undergoes wavefront-guided LASIK using the Visx S4 excimer laser.
Eligibility Criteria
You may qualify if:
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.75 diopters and -7.00 diopters with or without astigmatism of up to -3.50 diopters.
You may not qualify if:
- Subjects under the age of 21.
- Patients with thin corneas.
- Patients with topographic irregularities.
- Patients with keratoconus.
- Patients with autoimmune diseases.
- Patients who are pregnant or nursing.
- Patients must have similar levels of nearsightedness in each eye. They can not be more than 1.0 diopter of difference between eyes.
- Patients must have similar levels of astigmatism in each eye. They can not have more than 1.0 diopter of difference between eyes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (1)
Manche EE, Haw WW. Wavefront-guided laser in situ keratomileusis (Lasik) versus wavefront-guided photorefractive keratectomy (Prk): a prospective randomized eye-to-eye comparison (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2011 Dec;109:201-20.
PMID: 22253488RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward E. Manche
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Ophthalmology
Study Record Dates
First Submitted
June 2, 2010
First Posted
June 9, 2010
Study Start
August 1, 2006
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
April 11, 2022
Record last verified: 2022-04