Clinical trial NCT05588882: Wavefront-guided vs. Topography-guided LASIK
Official title: A Prospective Randomized Comparison of Topography-Guided LASIK Surgery to Wavefront-Guided LASIK Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: wavefront-guided
topography-guided
LASIK
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants contribute one eye to each study arm
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Percentage of eyes achieving uncorrected visual acuity
timeFrame: One year
Secondary outcomes:
measure: Percentage of eyes with a change in two or more lines of corrected visual acuity
timeFrame: One year
measure: Predictability
timeFrame: One year
measure: Patient Quality of Vision
timeFrame: One year
measure: Change in corneal epithelial thickness
timeFrame: One year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Edward E Manche, MD
role: PRINCIPAL_INVESTIGATOR
References: