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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: cornea@stanford.edu
• Phone: 650 725 5765

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.