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

Surgery Clinical Trial

Official title:

Outcomes of Topography-guided LASIK and Photorefractive Keratectomy Compared to Wavefront Optimized LASIK and Photorefractive Keratectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03075176
• Other study ID #: IRB # 95434
• Status: Terminated
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: August 12, 2019

Study information

• Verified date: June 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: August 12, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Surgery

Intervention

Device:
• Wavefront optimized LASIK
Wavefront optimized laser vision correction
• Wavefront optimized Photorefractive Keratectomy
Wavefront optimized laser vision correction
• Topography-guided LASIK
Topography-guided laser vision correction
• Topography-guided Photorefractive Keratectomy
Topography-guided laser vision correction

Locations

Country	Name	City	State
United States	Moran Eye Center - Midvalley Location	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Quality of Life Score From Baseline to 3 Months	The validated Quality of Life Impact of Refractive Correction survey will be administered pre-operatively and 3 months post surgery	3 months
Primary	Change in Uncorrected Visual Acuity From Baseline to Month 12	Uncorrected visual acuity will be tested pre-operatively through month 12	12 months
Secondary	Change in Contrast Sensitivity From Baseline to Month 3	Contrast sensitivity will be tested pre-operatively and 3 months post-operatively	3 months