Wavefront-guided PRK vs Wavefront-optimized PRK
A Prospective, Randomized Comparison of Fellow Eyes Undergoing Wavefront-guided PRK Versus Wavefront-optimized PRK Using the Alcon Allegretto Eye-Q 400 Excimer Laser
1 other identifier
interventional
71
1 country
1
Brief Summary
The purpose of the study is to compare the results of PRKK surgery when using wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser treatment in patients with nearsightedness with and without astigmatism
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2009
Typical duration for not_applicable
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
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2012
CompletedFirst Submitted
Initial submission to the registry
March 9, 2014
CompletedFirst Posted
Study publicly available on registry
March 19, 2014
CompletedDecember 8, 2021
November 1, 2021
3 years
March 9, 2014
November 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Uncorrected visual acuity
Uncorrected visual acuity
One year
Secondary Outcomes (7)
Topographic analysis
One year
Wavefront analysis
One year
Quality of vision and quality of life questionnaire
One year
Corneal haze
One year
Changes in best corrected 5 and 25% contrast visual acuity
One year
- +2 more secondary outcomes
Study Arms (2)
Wavefront-guided PRK
ACTIVE COMPARATORWavefront-guided PRK
Wavefront-optimized PRK
ACTIVE COMPARATORWavefront-optimized PRK
Interventions
Wavefront-guided PRK
Wavefront-optimized PRK
Eligibility Criteria
You may qualify if:
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.25 diopters and -8.00 diopters with or without astigmatism of up to 5.00 diopters.
You may not qualify if:
- Subjects under the age of 21.
- Excessively thin corneas.
- Topographic evidence of keratoconus.
- Ectactic eye disorders.
- Autoimmune diseases.
- Pregnant or nursing.
- Patients must have similar levels of nearsightedness in each eye. They can not be more than 2.5 diopter of difference between eyes.
- Patients must have similar levels of astigmatism in each eye. They can not have more than 1.5 diopter of difference between eyes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford Eye Laser Center
Palo Alto, California, 94303, United States
Related Publications (1)
He L, Manche EE. Contralateral eye-to-eye comparison of wavefront-guided and wavefront-optimized photorefractive keratectomy: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):51-9. doi: 10.1001/jamaophthalmol.2014.3876.
PMID: 25321951RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward E Manche, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Ophthalmology
Study Record Dates
First Submitted
March 9, 2014
First Posted
March 19, 2014
Study Start
April 1, 2009
Primary Completion
March 31, 2012
Study Completion
March 31, 2012
Last Updated
December 8, 2021
Record last verified: 2021-11