Wavefront-guided vs. Topography-guided LASIK
The study is comparing outcomes of wavefront-guided LASIK to topography-guided LASIK in a randomized contralateral fellow eye study in myopic participants.
|Condition or Disease||Intervention/Treatment||Phase|
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
We are using three FDA-approved laser devices for the study.
We are using two excimer lasers 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. We are using a Johnson and Johnson Visx CustomVue excimer laser and an Alcon Allegretto laser in the study. Both have received FDA-approval via a PMA pathway.
We are using one femtosecond laser for the study. The femtosecond laser is used to create the LASIK flap during the first part of the LASIK procedure. We are using an Intralase iFS150 femtosecond laser in the study. The femtosecond laser received FDA- approval via a 510k pathway.
All three lasers are being used according to their approved indications.
Arms and Interventions
|Active Comparator: Wavefront-guided LASIK
Wavefront-guided LASIK for myopia and myopic astigmatism
Procedure: Wavefront-guided LASIK
Topography-guided utilizes topography mapping to perform the ablation
|Active Comparator: Topography-guided LASIK
Topography-guided LASIK for myopia and myopic astigmatism
Wavefront-guided utilizes aberrometry to perform the ablation
Primary Outcome Measures
- Percentage of eyes achieving uncorrected visual acuity [One year]
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
Secondary Outcome Measures
- Percentage of eyes with a change in two or more lines of corrected visual acuity [One year]
Percentage of eyes gaining or losing two or more lines of corrected visual acuity Percentage of eyes gaining or losing 2 or more lines of corrected distance visual acuity
- Predictability [One year]
Percentage of eyes within +/- 0.50 and +/- 1.00 diopters of the intended corrected
- Patient Quality of Vision [One year]
Percentage of patients preferring the eye that underwent either Wavefront-guided or Topography-guided LASIK
- Change in corneal epithelial thickness [One year]
We will be measuring the average change in central corneal epithelial thickness from preoperative to post-operative month12 in eyes undergoing Wavefront-guided LASIK and Topography-guided LASIK
Subjects ages 22 and older with healthy eyes. Nearsightedness between -1.00 diopters and -9.00 diopters.
Subjects with less than or equal to 3.00 diopters of astigmatism.
Subjects under the age of 22.
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.
Contacts and Locations
LocationsNo locations specified.
Sponsors and Collaborators
- Stanford University
- Principal Investigator: Edward E Manche, Md, Stanford University
Study Documents (Full-Text)None provided.