Wavefront-guided vs. Topography-guided LASIK

NCT05588882 | Completed

• 1 other identifier: 63961
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study is comparing outcomes of wavefront-guided LASIK to topography-guided LASIK in a randomized contralateral fellow eye study in myopic participants.

Conditions

Myopia

Keywords

wavefront-guided; topography-guided; LASIK

Outcome Measures

Primary Outcomes (1)

• Percentage of eyes achieving uncorrected visual acuity

  Percentage of eyes achieving an uncorrected visual acuity of 20/40, 20/25 ,20/20, 20/16, 20/12.5 and 20/10 at post-operative month twelve

  One year

Secondary Outcomes (4)

• Percentage of eyes with a change in two or more lines of corrected visual acuity

  One year

• Predictability

  One year

• Patient Quality of Vision

  One year

• Change in corneal epithelial thickness

  One year

Study Arms (2)

Wavefront-guided LASIK

ACTIVE COMPARATOR

Wavefront-guided LASIK for myopia and myopic astigmatism

Procedure: Wavefront-guided LASIK

Topography-guided LASIK

ACTIVE COMPARATOR

Topography-guided LASIK for myopia and myopic astigmatism

Procedure: Wavefront-guided

Interventions

Wavefront-guided LASIK PROCEDURE

Topography-guided utilizes topography mapping to perform the ablation

Also known as: Topography-guided LASIK

Wavefront-guided LASIK

Wavefront-guided PROCEDURE

Wavefront-guided utilizes aberrometry to perform the ablation

Topography-guided LASIK

Eligibility Criteria

• Age: 22 Years - 59 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects ages 22 to 59with healthy eyes. Nearsightedness between -1.00 diopters and -9.00 diopters.
• Subjects with less than or equal to 3.00 diopters of astigmatism.

You may not qualify if:

• Subjects under the age of 22 and over the age of 59
• Subjects with excessively thin corneas.
• Subjects with topographic evidence of keratoconus.
• Subjects with ectactic eye disorders.
• Subjects with autoimmune diseases.
• Subjects who are pregnant or nursing.
• Subjects must have similar levels of nearsightedness in each eye. They cannot be more than 1.5 diopter of difference between eyes.
• Subjects with more than 3.00 diopters of astigmatism
• Subjects must have similar levels of astigmatism in each eye. They cannot have more than 1.00 diopters of difference between eyes.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94303, United States

Location

Related Publications (1)

• Lu L, Manche E. Prospective, randomized, contralateral eye comparison of wavefront-guided and topography-guided LASIK. J Cataract Refract Surg. 2025 Oct 1;51(10):889-894. doi: 10.1097/j.jcrs.0000000000001703.

  PMID: 40778939 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Edward E Manche, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Model Details: Participants contribute one eye to each study arm

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: October 19, 2022
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)