LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser vs AMO Visx Wavefront-Guided Excimer Laser
LASIK
A Prospective Eye to Eye Comparison of LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser Versus AMO Visx Wavefront-Guided Excimer Laser
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of the study is to compare the results of LASIK surgery when using Alcon Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided excimer laser system 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 phase_4
Started Apr 2009
Typical duration for phase_4
1 active site
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
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2011
CompletedFirst Submitted
Initial submission to the registry
October 6, 2011
CompletedFirst Posted
Study publicly available on registry
October 19, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2012
CompletedApril 11, 2022
April 1, 2022
2 years
October 6, 2011
April 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
Efficacy measures uncorrected visual acuity following the LASIK surgery. We will record how many eyes see 20/40, 20/30, 20/25, 20/20, 20/16, 20/12.5 and 20/10 after the surgery without glasses or contact lenses. We are measuring how well patients see after the surgery without glasses or contact lenses.
1 year
Secondary Outcomes (4)
Low contrast visual acuity
1 year
Higher order aberrations
1 year
Safety
One year
Predictability
One year
Study Arms (2)
Wavefront-guided LASIK - Allegretto
ACTIVE COMPARATORWavefront-guided LASIK using the Allegretto excimer laser.
Wavefront-guided LASIK - AMO
ACTIVE COMPARATORWavefront-guided LASIK using AMO CustomVue excimer laser.
Interventions
Wavefront-guided LASIK using the Allegretto excimer laser for myopia.
Wavefront-guided LASIK using the AMO CustomVue excimer laser for myopia.
Eligibility Criteria
You may qualify if:
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.50 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 ectatic eye disorders.
- Patients with autoimmune diseases.
- Patients who are pregnant or nursing.
- Patients must have similar levels of nearsightedness with or without astigmatism in each eye.
- They can not be more than 1.5 diopters of difference between eyes.
- Patients must have similar levels of astigmatism in each eye.
- They can not have more than 1.5 diopters of difference in nearsightedness or astigmatism between their two eyes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Byers Eye Institute at Stanford
Palo Alto, California, 94303, United States
Related Publications (6)
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: 25321951BACKGROUNDHe L, Manche EE. Prospective randomized contralateral eye evaluation of subjective quality of vision after wavefront-guided or wavefront- optimized photorefractive keratectomy. J Refract Surg. 2014 Jan;30(1):6-12. doi: 10.3928/1081597X-20131217-01.
PMID: 24868564BACKGROUNDLee WS, Manche EE. Comparison of simulated keratometric changes following wavefront-guided and wavefront-optimized myopic laser-assisted in situ keratomileusis. Clin Ophthalmol. 2018 Mar 29;12:613-619. doi: 10.2147/OPTH.S161387. eCollection 2018.
PMID: 29636597BACKGROUNDHe L, Liu A, Manche EE. Wavefront-guided versus wavefront-optimized laser in situ keratomileusis for patients with myopia: a prospective randomized contralateral eye study. Am J Ophthalmol. 2014 Jun;157(6):1170-1178.e1. doi: 10.1016/j.ajo.2014.02.037. Epub 2014 Feb 19.
PMID: 24560995BACKGROUNDSales 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: 23778091BACKGROUNDSales CS, Manche EE. One-year eye-to-eye comparison of wavefront-guided versus wavefront-optimized laser in situ keratomileusis in hyperopes. Clin Ophthalmol. 2014 Nov 12;8:2229-38. doi: 10.2147/OPTH.S70145. eCollection 2014.
PMID: 25419115BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward E Manche, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- 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
October 6, 2011
First Posted
October 19, 2011
Study Start
April 1, 2009
Primary Completion
March 31, 2011
Study Completion
June 23, 2012
Last Updated
April 11, 2022
Record last verified: 2022-04