Clinical trial NCT03075176: Topo-guided LASIK and Photorefractive Keratectomy vs Wavefront LASIK and Photorefractive Keratectomy
Official title: Outcomes of Topography-guided LASIK and Photorefractive Keratectomy Compared to Wavefront Optimized LASIK and Photorefractive Keratectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Myopia
Keywords: Photorefractive keratectomy
Laser-assisted in situ keratomileusis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant will receive wavefront optimized surgery in one eye and topography-guided surgery in the second eye.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Uncorrected Visual Acuity From Baseline to Month 12
timeFrame: 12 months
Secondary outcomes:
measure: Change in Contrast Sensitivity From Baseline to Month 3
timeFrame: 3 months
Other outcomes:
measure: Change in Quality of Life Score From Baseline to 3 Months
timeFrame: 3 months
Locations:
city: Murray
country: United States
facility: Moran Eye Center - Midvalley Location
state: Utah
Study officials:
affiliation: University of Utah Moran Eye Center
name: Mark Mifflin, MD
role: PRINCIPAL_INVESTIGATOR
References: