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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2019-08-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgery Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each participant will receive wavefront optimized surgery in one eye and topography-guided surgery in the second eye.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants will be masked as to which type of surgery they receive in either eye.

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Wavefront optimized LASIK

Intervention Type DEVICE

Wavefront optimized laser vision correction

Topography-guided LASIK

Intervention Type DEVICE

Topography-guided laser vision correction

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).

Group Type ACTIVE_COMPARATOR

Wavefront optimized Photorefractive Keratectomy

Intervention Type DEVICE

Wavefront optimized laser vision correction

Topography-guided Photorefractive Keratectomy

Intervention Type DEVICE

Topography-guided laser vision correction

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).

Group Type ACTIVE_COMPARATOR

Wavefront optimized LASIK

Intervention Type DEVICE

Wavefront optimized laser vision correction

Topography-guided LASIK

Intervention Type DEVICE

Topography-guided laser vision correction

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).

Group Type ACTIVE_COMPARATOR

Wavefront optimized Photorefractive Keratectomy

Intervention Type DEVICE

Wavefront optimized laser vision correction

Topography-guided Photorefractive Keratectomy

Intervention Type DEVICE

Topography-guided laser vision correction

Interventions

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Wavefront optimized LASIK

Wavefront optimized laser vision correction

Intervention Type DEVICE

Wavefront optimized Photorefractive Keratectomy

Wavefront optimized laser vision correction

Intervention Type DEVICE

Topography-guided LASIK

Topography-guided laser vision correction

Intervention Type DEVICE

Topography-guided Photorefractive Keratectomy

Topography-guided laser vision correction

Intervention Type DEVICE

Eligibility Criteria

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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)