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

Utah System of Higher Education (USHE)

Status: Terminated

Conditions: Myopia; Surgery

Treatments: Device: Topography-guided Photorefractive Keratectomy; Device: Wavefront optimized LASIK; Device: Wavefront optimized Photorefractive Keratectomy; Device: Topography-guided LASIK

Study type: Interventional

Funder types: Other

Identifiers

NCT03075176

IRB # 95434

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 4 patient groups

Wavefront optimized LASIK

Active Comparator group

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).

Treatment:

Device: Wavefront optimized LASIK

Device: Topography-guided LASIK

Wavefront optimized Photorefractive Keratectomy

Active Comparator group

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).

Treatment:

Device: Wavefront optimized Photorefractive Keratectomy

Device: Topography-guided Photorefractive Keratectomy

Topography-guided LASIK

Active Comparator group

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).

Treatment:

Device: Wavefront optimized LASIK

Device: Topography-guided LASIK

Topography-guided Photorefractive Keratectomy

Active Comparator group

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).

Treatment:

Device: Wavefront optimized Photorefractive Keratectomy

Device: Topography-guided Photorefractive Keratectomy