Wavefront-guided vs. Topography-guided LASIK

Stanford University

Status

Completed

Conditions

Myopia

Treatments

Procedure: Wavefront-guided

Procedure: Wavefront-guided LASIK

Study type

Interventional

Funder types

Other

Identifiers

NCT05588882

63961

Details and patient eligibility

About

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

Full description

The purpose of the study is to compare the results of wavefront-guided LASIK surgery to topography-guided LASIK surgery in participants with nearsightedness with or without astigmatism

Three FDA-approved laser devices are being used for the study.

Two excimer lasers are being used for the study. The excimer laser is used to perform the reshaping of the cornea under a LASIK flap to correct nearsightedness, farsightedness and astigmatism. The two lasers being utilized are the Johnson and Johnson Visx CustomVue excimer laser and the Alcon Allegretto laser in the study. Both have received FDA-approval via a PMA pathway.

One femtosecond laser is being used in the study. The femtosecond laser is used to create the LASIK flap during the first part of the LASIK procedure. The Intralase iFS150 femtosecond laser is being used in the study. The femtosecond laser received FDA- approval via a 510k pathway.

All three lasers are being used according to their approved indications.

Enrollment

50 patients

Sex

All

Ages

22 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria.

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.

Exclusion criteria.

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.