search
Back to results

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

Primary Purpose

Surgery, Myopia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wavefront optimized LASIK
Wavefront optimized Photorefractive Keratectomy
Topography-guided LASIK
Topography-guided Photorefractive Keratectomy
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring Photorefractive keratectomy, Laser-assisted in situ keratomileusis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Moran Eye Center - Midvalley Location

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Wavefront optimized LASIK

Wavefront optimized Photorefractive Keratectomy

Topography-guided LASIK

Topography-guided Photorefractive Keratectomy

Arm Description

Participants who chose to have LASIK surgery were assigned to have Wavefront optimized LASIK in one eye and Topography-guided LASIK in the other eye (randomly chosen).

Participants who chose to have Photorefractive Keratectomy surgery were assigned to have Wavefront optimized Photorefractive Keratectomy in one eye and Topography-guided Photorefractive Keratectomy in the other eye (randomly chosen).

Participants who chose to have LASIK surgery were assigned to have Topography-guided LASIK in one eye and Wavefront optimized LASIK in the other eye (randomly chosen).

Participants who chose to have Photorefractive Keratectomy surgery were assigned to have Topography-guided Photorefractive Keratectomy in one eye and Wavefront optimized Photorefractive Keratectomy in the other eye (randomly chosen).

Outcomes

Primary Outcome Measures

Change in Uncorrected Visual Acuity From Baseline to Month 12
Uncorrected visual acuity will be tested pre-operatively through month 12

Secondary Outcome Measures

Change in Contrast Sensitivity From Baseline to Month 3
Contrast sensitivity will be tested pre-operatively and 3 months post-operatively

Full Information

First Posted
February 18, 2017
Last Updated
June 23, 2023
Sponsor
University of Utah
search

1. Study Identification

Unique Protocol Identification Number
NCT03075176
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Because of the bias in who qualified for the study it became apparent we would not get any statistically valid results.
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
August 12, 2019 (Actual)
Study Completion Date
August 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Myopia
Keywords
Photorefractive keratectomy, Laser-assisted in situ keratomileusis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each participant will receive wavefront optimized surgery in one eye and topography-guided surgery in the second eye.
Masking
Participant
Masking Description
Participants will be masked as to which type of surgery they receive in either eye.
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wavefront optimized LASIK
Arm Type
Active Comparator
Arm Description
Participants who chose to have LASIK surgery were assigned to have Wavefront optimized LASIK in one eye and Topography-guided LASIK in the other eye (randomly chosen).
Arm Title
Wavefront optimized Photorefractive Keratectomy
Arm Type
Active Comparator
Arm Description
Participants who chose to have Photorefractive Keratectomy surgery were assigned to have Wavefront optimized Photorefractive Keratectomy in one eye and Topography-guided Photorefractive Keratectomy in the other eye (randomly chosen).
Arm Title
Topography-guided LASIK
Arm Type
Active Comparator
Arm Description
Participants who chose to have LASIK surgery were assigned to have Topography-guided LASIK in one eye and Wavefront optimized LASIK in the other eye (randomly chosen).
Arm Title
Topography-guided Photorefractive Keratectomy
Arm Type
Active Comparator
Arm Description
Participants who chose to have Photorefractive Keratectomy surgery were assigned to have Topography-guided Photorefractive Keratectomy in one eye and Wavefront optimized Photorefractive Keratectomy in the other eye (randomly chosen).
Intervention Type
Device
Intervention Name(s)
Wavefront optimized LASIK
Intervention Description
Wavefront optimized laser vision correction
Intervention Type
Device
Intervention Name(s)
Wavefront optimized Photorefractive Keratectomy
Intervention Description
Wavefront optimized laser vision correction
Intervention Type
Device
Intervention Name(s)
Topography-guided LASIK
Intervention Description
Topography-guided laser vision correction
Intervention Type
Device
Intervention Name(s)
Topography-guided Photorefractive Keratectomy
Intervention Description
Topography-guided laser vision correction
Primary Outcome Measure Information:
Title
Change in Uncorrected Visual Acuity From Baseline to Month 12
Description
Uncorrected visual acuity will be tested pre-operatively through month 12
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Contrast Sensitivity From Baseline to Month 3
Description
Contrast sensitivity will be tested pre-operatively and 3 months post-operatively
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Change in Quality of Life Score From Baseline to 3 Months
Description
The validated Quality of Life Impact of Refractive Correction survey will be administered pre-operatively and 3 months post surgery
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Mifflin, MD
Organizational Affiliation
University of Utah Moran Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moran Eye Center - Midvalley Location
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs