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NCT01135719 Clinical Trial

A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

Myopia Clinical Trial

Official title:
A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01135719
Other study ID # SU-04302009-2458
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2009
Est. completion date December 3, 2022

Study information
Verified date December 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.

Description:

Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.

Recruitment information / eligibility
Status Completed
Enrollment 137
Est. completion date December 3, 2022
Est. primary completion date December 31, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria: - Healthy subjects age 21 and older. - Subjects with nearsightedness, farsightedness and/or astigmatism. Exclusion Criteria:Autoimmune diseases. - Children. - Women pregnant or nursing. - Ectatic corneal disease. - Previous ocular surgery.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• LASIK and PRK
Wavefront-guided versus wavefront-optimized LASIK or PRK.

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Edward E. Manche

Country where clinical trial is conducted

United States, 

References & Publications (6)

He 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. — View Citation

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. Erratum In: JAMA Ophthalmol. 2015 May;133(5):621. — View Citation

Kung JS, Manche EE. Quality of Vision After Wavefront-Guided or Wavefront-Optimized LASIK: A Prospective Randomized Contralateral Eye Study. J Refract Surg. 2016 Apr;32(4):230-6. doi: 10.3928/1081597X-20151230-01. — View Citation

Lee MD, Toy BC, Manche EE. Astigmatic outcomes in myopic wavefront-guided laser in situ keratomileusis versus wavefront-guided photorefractive keratectomy using vector analysis. J Cataract Refract Surg. 2018 Nov;44(11):1350-1354. doi: 10.1016/j.jcrs.2018.07.022. Epub 2018 Sep 7. — View Citation

Sales 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. — View Citation

Smith RG, Manche EE. One-Year Outcomes From a Prospective, Randomized, Eye-to-Eye Comparison of Wavefront-Guided and Wavefront-Optimized PRK in Myopia. J Refract Surg. 2020 Mar 1;36(3):160-168. doi: 10.3928/1081597X-20200129-01. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in best spectacle corrected visual acuity. One year
Primary Changes in 25 and 5% low contrast visual acuity. One year
Primary Improvement in uncorrected visual acuity One year
Secondary Changes in higher order aberrations. One year
Secondary Topographic changes. One year
Secondary Quality of vision changes. One year
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