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

Not Applicable

Terminated

• Conditions: Surgery; Myopia
• Interventions: Device: Wavefront optimized LASIK; Device: Wavefront optimized Photorefractive Keratectomy; Device: Topography-guided Photorefractive Keratectomy; Device: Topography-guided LASIK

• Registration Number: NCT03075176
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study Start: 2017-02-13
• Study First Submitted: 2017-02-18
• Study First Submitted QC: 2017-03-04
• Study First Posted: 2017-03-09
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Results First Submitted: 2022-12-05
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-23
• Last Update Submitted: 2023-06-23
• Results First Posted: 2023-07-17
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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)

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Exclusion Criteria

• Any patient who is not a suitable candidate for LASIK or PRK will not be included.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topography-guided LASIK	Wavefront optimized 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).
Topography-guided Photorefractive Keratectomy	Wavefront optimized 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).
Topography-guided Photorefractive Keratectomy	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).
Wavefront optimized Photorefractive Keratectomy	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).
Wavefront optimized LASIK	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).
Wavefront optimized LASIK	Topography-guided 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).
Wavefront optimized Photorefractive Keratectomy	Topography-guided 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).
Topography-guided LASIK	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).

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Moran Eye Center - Midvalley Location; 🇺🇸 Murray, Utah, United States