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The study is comparing outcomes of wavefront-guided LASIK to topography-guided LASIK in a randomized contralateral fellow eye study in myopic participants.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wavefront-guided LASIK | Active Comparator | Wavefront-guided LASIK for myopia and myopic astigmatism |
|
| Topography-guided LASIK | Active Comparator | Topography-guided LASIK for myopia and myopic astigmatism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wavefront-guided LASIK | Procedure | Topography-guided utilizes topography mapping to perform the ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes with a change in two or more lines of corrected visual acuity | 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 | One year |
| Predictability |
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Inclusion criteria.
Exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Edward E Manche, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Palo Alto | California | 94303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40778939 | Derived | 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. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Participants contribute one eye to each study arm
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| Wavefront-guided | Procedure | Wavefront-guided utilizes aberrometry to perform the ablation |
|
Percentage of eyes within +/- 0.50 and +/- 1.00 diopters of the intended corrected |
| One year |
| Patient Quality of Vision | Percentage of patients preferring the eye that underwent either Wavefront-guided or Topography-guided LASIK | One year |
| Change in corneal epithelial thickness | 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 | One year |