Study Stopped
Because of the bias in who qualified for the study it became apparent we would not get any statistically valid results.
Topo-guided LASIK and Photorefractive Keratectomy vs Wavefront LASIK and Photorefractive Keratectomy
Outcomes of Topography-guided LASIK and Photorefractive Keratectomy Compared to Wavefront Optimized LASIK and Photorefractive Keratectomy
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable surgery
Started Feb 2017
Typical duration for not_applicable surgery
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2017
CompletedFirst Submitted
Initial submission to the registry
February 18, 2017
CompletedFirst Posted
Study publicly available on registry
March 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2019
CompletedResults Posted
Study results publicly available
July 17, 2023
CompletedJuly 17, 2023
June 1, 2023
2.5 years
February 18, 2017
December 5, 2022
June 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Uncorrected Visual Acuity From Baseline to Month 12
Uncorrected visual acuity will be tested pre-operatively through month 12
12 months
Secondary Outcomes (1)
Change in Contrast Sensitivity From Baseline to Month 3
3 months
Other Outcomes (1)
Change in Quality of Life Score From Baseline to 3 Months
3 months
Study Arms (4)
Wavefront optimized LASIK
ACTIVE COMPARATORParticipants 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).
Wavefront optimized Photorefractive Keratectomy
ACTIVE COMPARATORParticipants 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).
Topography-guided LASIK
ACTIVE COMPARATORParticipants 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).
Topography-guided Photorefractive Keratectomy
ACTIVE COMPARATORParticipants 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).
Interventions
Wavefront optimized laser vision correction
Wavefront optimized laser vision correction
Topography-guided laser vision correction
Topography-guided laser vision correction
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Any patient who is not a suitable candidate for LASIK or PRK will not be included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moran Eye Center - Midvalley Location
Murray, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early. Because of strong selection bias in who qualified for the study, it became apparent we would not get any statistically valid results.
Results Point of Contact
- Title
- Mark Mifflin, MD
- Organization
- University of Utah John A. Moran Eye Center
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Mifflin, MD
University of Utah Moran Eye Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be masked as to which type of surgery they receive in either eye.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Ophthalmology/Visual Sciences
Study Record Dates
First Submitted
February 18, 2017
First Posted
March 9, 2017
Study Start
February 13, 2017
Primary Completion
August 12, 2019
Study Completion
August 12, 2019
Last Updated
July 17, 2023
Results First Posted
July 17, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share