Topo-guided LASIK and Photorefractive Keratectomy vs Wavefront LASIK and Photorefractive Keratectomy
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Wavefront optimized LASIK 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). |
Device: Wavefront optimized LASIK
Wavefront optimized laser vision correction
Device: Topography-guided LASIK
Topography-guided laser vision correction
|
| Active Comparator: Wavefront optimized Photorefractive Keratectomy 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). |
Device: Wavefront optimized Photorefractive Keratectomy
Wavefront optimized laser vision correction
Device: Topography-guided Photorefractive Keratectomy
Topography-guided laser vision correction
|
| Active Comparator: Topography-guided LASIK 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). |
Device: Wavefront optimized LASIK
Wavefront optimized laser vision correction
Device: Topography-guided LASIK
Topography-guided laser vision correction
|
| Active Comparator: Topography-guided Photorefractive Keratectomy 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). |
Device: Wavefront optimized Photorefractive Keratectomy
Wavefront optimized laser vision correction
Device: Topography-guided Photorefractive Keratectomy
Topography-guided laser vision correction
|
Outcome Measures
Primary Outcome Measures
- Change in uncorrected visual acuity from baseline to month 12 [12 months]
Uncorrected visual acuity will be tested pre-operatively through month 12
Secondary Outcome Measures
- Change in contrast sensitivity from baseline to month 3 [3 months]
Contrast sensitivity will be tested pre-operatively and 3 months post-operatively
Other Outcome Measures
- Change in degree of higher order aberrations from baseline to 3 months [3 months]
Aberrometry measurements will be taken pre-operatively and 3 months post surgery
- Change in quality of life score from baseline to 3 months [3 months]
The validated Quality of Life Impact of Refractive Correction survey will be administered pre-operatively and 3 months post surgery
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moran Eye Center - Midvalley Location | Murray | Utah | United States | 84107 |
Sponsors and Collaborators
- University of Utah
Investigators
- Principal Investigator: Mark Mifflin, MD, University of Utah Moran Eye Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB # 95434