Wavefront-guided Versus Wavefront-optimized LASIK for Nearsightedness
A Prospective Eye to Eye Comparison of LASIK Using Wavefront-guided Treatment Versus Wavefront-optimized Treatment
2 other identifiers
observational
36
1 country
1
Brief Summary
The purpose of the study is to compare the results of LASIK 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 P25-P50 for all trials
Started Apr 2010
Typical duration for all trials
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 6, 2010
CompletedFirst Submitted
Initial submission to the registry
June 3, 2010
CompletedFirst Posted
Study publicly available on registry
June 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2012
CompletedDecember 8, 2021
November 1, 2021
2.1 years
June 3, 2010
November 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Changes in best corrected visual acuity
12 months
Changes in 5 and 25% contrast visual acuity
12 months
Refractive predictability
12 months
Uncorrected visual acuity
12 months
Secondary Outcomes (3)
Changes in higher order aberrations
1 yr
Quality of vision measurement
1 yr
Topographic analysis
1 yr
Interventions
Wavefront-guided LASIK in one eye using the Allegretto excimer laser
Wavefront-optimized LASIK in one eye using the Allegretto excimer laser
Eligibility Criteria
Subjects age 21 and older with healthy eyes. Nearsightedness between -7.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters.
You may qualify if:
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -7.50 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 excessively thin corneas.
- Patients with topographic evidence of 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 3.0 diopter of difference between eyes.
- Patients must have similar levels of astigmatism in each eye. They can not have more than 4.0 diopters of difference in nearsightedness or astigmatism between their two eyes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Edward E. Manchelead
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (1)
Sales CS, Manche EE. One-year outcomes from a prospective, randomized, eye-to-eye comparison of wavefront-guided and wavefront-optimized LASIK in myopes. Ophthalmology. 2013 Dec;120(12):2396-2402. doi: 10.1016/j.ophtha.2013.05.010. Epub 2013 Jun 15.
PMID: 23778091RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward E. Manche
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Stanford University School of Medicine
Study Record Dates
First Submitted
June 3, 2010
First Posted
June 7, 2010
Study Start
April 6, 2010
Primary Completion
April 30, 2012
Study Completion
April 30, 2012
Last Updated
December 8, 2021
Record last verified: 2021-11