Wavefront-guided LASIK versus ray-tracing-guided LASIK in opposite eyes

A Prospective Randomized Comparison of Wavefront-guided LASIK Surgery to Ray Tracing-Guided LASIK Surgery

We will try wavefront-guided LASIK in one eye and ray-tracing-guided LASIK in the other eye of adults 22 and older with nearsightedness (with up to 3 diopters of astigmatism) to see if one gives better vision outcomes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 22 Years to 59 Years
• Sex: All
• Sponsor: Stanford University (other)
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT07078799 on ClinicalTrials.gov

What this trial studies

This single-center randomized comparison enrolls up to 70 adults with myopia (−1.00 to −10.00 D) and ≤3.00 D astigmatism to receive wavefront-guided LASIK in one eye and ray-tracing-guided LASIK in the fellow eye. Which eye receives which procedure is assigned at random before enrollment, and both procedures are performed according to FDA-approved labeling. Participants undergo preoperative baseline measurements and scheduled postoperative ophthalmic examinations to compare visual outcomes and safety between the two guidance methods. The within-patient design reduces variability by directly comparing both techniques in the same individual.

Who should consider this trial

Good fit: Adults aged 22 or older with healthy eyes, stable myopia between −1.00 and −10.00 diopters, ≤3.00 diopters of astigmatism, similar prescriptions between eyes, and who are willing to have one eye receive each procedure and attend follow-up visits.

Not a fit: Patients with excessively thin corneas, topographic evidence of keratoconus or other ectatic disorders, autoimmune disease, pregnancy or nursing, more than 3.00 D astigmatism, or >1.5 D difference between eyes are unlikely to be eligible or benefit from this comparison.

Why it matters

Potential benefit: If successful, the trial could identify which LASIK guidance method yields sharper vision or fewer side effects, helping patients and surgeons choose the better option.

How similar studies have performed: Both approaches are FDA-approved and wavefront-guided LASIK has extensive prior data while ray-tracing guidance is newer and direct randomized, within-patient comparisons are limited.

Eligibility criteria

Inclusion Criteria:

1. Age 22 and older
2. People with healthy eyes:

   1. No abnormal corneal shape
   2. No excessively thin corneas
   3. No eye diseases such as glaucoma or cataracts
3. Nearsightedness between -1.00 diopters and -10.00 diopters.
4. Subjects with less than or equal to 3.00 diopters of astigmatism.
5. Subjects must have similar levels of nearsightedness in each eye.

Exclusion Criteria:

1. Subjects under the age of 22.
2. Subjects with excessively thin corneas.
3. Subjects with topographic evidence of keratoconus.
4. Subjects with ectactic eye disorders.
5. Subjects with autoimmune diseases.
6. Subjects who are pregnant or nursing at the time of surgery. (The FDA-approved labelling indications for LASIK specifically excludes patients who are pregnant or nursing. There is no strict prohibition not to become pregnant during the one year study period)
7. They can not be more than 1.5 diopter of difference between eyes.
8. Subjects with more than 3.00 diopters of astigmatism
9. Subjects with disimilar levels of astigmatism in each eye (They can not have more than 0.75 diopters of difference between eyes) -

Where this trial is running

Palo Alto, California

• Byers Eye Institute at Stanford University School of Medicine — Palo Alto, California, United States (RECRUITING)

Study contacts

• Principal investigator: Edward E Manche, MD — Stanford University
• Study coordinator: Edward E Manche, MD

Conditions: Myopia, Astigmatism, Ray tracing-guided LASIK, Wavefront-guided LASIK