Wavefront-guided Versus Wavefront-optimized LASIK for Nearsightedness

A Prospective Eye to Eye Comparison of LASIK Using Wavefront-guided Treatment Versus Wavefront-optimized Treatment

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

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Procedure: Wavefront-guided LASIK; Procedure: Wavefront-optimized LASIK

Detailed Description

This is a research study comparing the outcomes of LASIK surgery for nearsightedness when using the two different excimer laser technologies. Patients will have both eyes treated with the Alcon WaveLight Allegretto excimer laser. You will be one of 150 sighted patients at Stanford to undergo treatment in this clinical research trial. This will be a prospective, randomized, research study in which up to 300 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) using one laser technology in the first eye and the second laser technology in the fellow eye for the correction of myopia (nearsightedness) with or without astigmatism will be enrolled. The choice of which eye receives the wavefront guided technology and which eye receives the wavefront-optimized technology will be randomized prior to enrollment. Randomization will be done according to a randomization schedule. You will know which eye is being treated with which each technology. The randomization will determine only whether your right or left eye is treated with the wavefront guided technology. The other eye will be treated with wavefront-optimized laser technology. You have a fifty percent chance of having your left eye treated with custom wavefront guided technology as your right eye. Subjects will undergo bilateral (both eyes at once) LASIK treatments using the Alcon WaveLight Allegretto excimer laser. All subjects will be followed for one year after the vision correction procedure. Subjects scheduled to undergo LASIK for the correction of myopia (nearsightedness) with or without astigmatism will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, subjects will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Retreatments (a second operation on the same eye for residual nearsightedness) will not be allowed during the first twelve months of this study. If you elect to undergo a retreatment of your LASIK surgery prior to the 12-month post-operative visit, the retreated eye will be exited from the study as of the retreatment date.

Any significant new finding developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject or subject's representative in a timely manner.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Changes in higher order aberrations	1 yr
Quality of vision measurement	1 yr
Topographic analysis	1 yr

Collaborators and Investigators

• Sponsor: Edward E. Manche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2010
• Primary Completion (Actual): April 30, 2012
• Study Completion (Actual): April 30, 2012

Study Registration Dates

• First Submitted: June 3, 2010
• First Submitted That Met QC Criteria: June 4, 2010
• First Posted (Estimate): June 7, 2010

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Wavefront-guided LASIK.; Wavefront-optimized LASIK.; Custom LASIK
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: SU-05272010-6188; Stanford Protocol # 18692