Topo-guided LASIK and Photorefractive Keratectomy vs Wavefront LASIK and Photorefractive Keratectomy

University of Utah39 enrolled

Overview

This study evaluates the difference in results between eyes that have been treated wavefront optimized laser vision correction (either LASIK or Photorefractive Keratectomy) compared to eyes treated with topography-guided laser vision correction (either LASIK or Photorefractive Keratectomy). Each participant will receive wavefront optimized correction in one eye and topography-guided correction in the other.

Participants will have an in depth discussion with our refractive surgery coordinator regarding refractive surgery. Patients will choose LASIK or Photorefractive Keratectomy surgery based on our standard pre-operative discussion that is provided to all patients. As is standard for laser refractive candidates, the advantages and disadvantages of LASIK and Photorefractive Keratectomy compared to the other refractive surgical options will be discussed. Following patient selection of their preferred type of refractive procedure they will be randomized as discussed below, and only patients who elect for LASIK or Photorefractive Keratectomy will be included in our study. Prior to surgery, one eye from each patient will be randomly assigned to receive either Wavefront optimized or Topography Guided treatment. Each patient in the study will have a fellow eye enrolled in the other treatment group. Patients will either receive LASIK treatment or Photorefractive Keratectomy treatment in both eyes but the eyes will be randomized to topography guided or wavefront optimized forms of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Surgery Myopia

Interventions

Wavefront optimized LASIKDEVICE

Wavefront optimized laser vision correction

Wavefront optimized Photorefractive KeratectomyDEVICE

Wavefront optimized laser vision correction

Topography-guided LASIKDEVICE

Topography-guided laser vision correction

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All subjects who are deemed suitable candidates for laser refractive surgery after routine refractive surgery screening will be considered eligible for participation in this study. Subjects must be at least 21 years of age and not pregnant or nursing (due to fluctuations in visual parameters during pregnancy) Exclusion Criteria: * Any patient who is not a suitable candidate for LASIK or PRK will not be included.

Locations (1)

Moran Eye Center - Midvalley Location

Murray, Utah, United States

Outcomes

Primary Outcomes

Change in Uncorrected Visual Acuity From Baseline to Month 12

Uncorrected visual acuity will be tested pre-operatively through month 12

Time frame: 12 months

Secondary Outcomes

Change in Contrast Sensitivity From Baseline to Month 3

Contrast sensitivity will be tested pre-operatively and 3 months post-operatively

Time frame: 3 months

Data from ClinicalTrials.gov

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