Wavefront-guided vs. Topography-guided LASIK

Stanford University50 enrolled

Overview

The study is comparing outcomes of wavefront-guided LASIK to topography-guided LASIK in a randomized contralateral fellow eye study in myopic participants.

The purpose of the study is to compare the results of wavefront-guided LASIK surgery to topography-guided LASIK surgery in participants with nearsightedness with or without astigmatism Three FDA-approved laser devices are being used for the study. Two excimer lasers are being used for the study. The excimer laser is used to perform the reshaping of the cornea under a LASIK flap to correct nearsightedness, farsightedness and astigmatism. The two lasers being utilized are the Johnson and Johnson Visx CustomVue excimer laser and the Alcon Allegretto laser in the study. Both have received FDA-approval via a PMA pathway. One femtosecond laser is being used in the study. The femtosecond laser is used to create the LASIK flap during the first part of the LASIK procedure. The Intralase iFS150 femtosecond laser is being used in the study. The femtosecond laser received FDA- approval via a 510k pathway. All three lasers are being used according to their approved indications.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myopia

Interventions

Wavefront-guided LASIKPROCEDURE

Topography-guided utilizes topography mapping to perform the ablation

Wavefront-guidedPROCEDURE

Wavefront-guided utilizes aberrometry to perform the ablation

Eligibility

Sex: ALLMin age: 22 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria. * Subjects ages 22 to 59with healthy eyes. Nearsightedness between -1.00 diopters and -9.00 diopters. * Subjects with less than or equal to 3.00 diopters of astigmatism. Exclusion criteria. * Subjects under the age of 22 and over the age of 59 * Subjects with excessively thin corneas. * Subjects with topographic evidence of keratoconus. * Subjects with ectactic eye disorders. * Subjects with autoimmune diseases. * Subjects who are pregnant or nursing. * Subjects must have similar levels of nearsightedness in each eye. They cannot be more than 1.5 diopter of difference between eyes. * Subjects with more than 3.00 diopters of astigmatism * Subjects must have similar levels of astigmatism in each eye. They cannot have more than 1.00 diopters of difference between eyes.

Locations (1)

Stanford University School of Medicine

Palo Alto, California, United States

Outcomes

Primary Outcomes

Percentage of eyes achieving uncorrected visual acuity

Percentage of eyes achieving an uncorrected visual acuity of 20/40, 20/25 ,20/20, 20/16, 20/12.5 and 20/10 at post-operative month twelve

Time frame: One year

Secondary Outcomes

Percentage of eyes with a change in two or more lines of corrected visual acuity

Percentage of eyes gaining or losing two or more lines of corrected visual acuity Percentage of eyes gaining or losing 2 or more lines of corrected distance visual acuity

Time frame: One year

Predictability

Percentage of eyes within +/- 0.50 and +/- 1.00 diopters of the intended corrected

Time frame: One year

Patient Quality of Vision

Percentage of patients preferring the eye that underwent either Wavefront-guided or Topography-guided LASIK

Time frame: One year

Change in corneal epithelial thickness

We will be measuring the average change in central corneal epithelial thickness from preoperative to post-operative month12 in eyes undergoing Wavefront-guided LASIK and Topography-guided LASIK

Time frame: One year

Data from ClinicalTrials.gov

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