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Eye to Eye Comparison of SMILE Surgery to LASIK Surgery

January 10, 2020

Overview

Stanford University is holding a study on the best way to correct myopia (nearsightedness): LASIK surgery or SMILE surgery. Subjects will be screened using computerized videokeratography. Those who are selected will undergo bilateral simultaneous eye surgery. One eye will be treated with SMILE surgery and the other will be treated with WFG-LASIK surgery. The eyes and treatment will be randomly assigned. 

 

Study Information

This study has an estimated enrollment of 70 participants. Subjects will be monitored for one year for 

  • Change in CDVA
  • Aberrometry measurements
  • Satisfaction through a PROWL questionnaire
  • Change in corneal sensation
  • Dry eye symptoms and signs
  • Vector analysis of astigmatism
  • Anterior segment ocular coherence topography analysis
  • Predictability (Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction)
  • Stability (Change in refractive error over 1 to 12 months).

 

Inclusion Criteria

 

All sexes, ages 22 to 59 years old, are allowed to participate. To be included in the study, participants must have healthy eyes, with nearsightedness between -0.75 diopters and -8.00 diopters and less than 0.75 diopters of astigmatism.

 

Exclusion Criteria

 

Those not allowed to participate are:

  • Under the age of 22.
  • Subjects excessively thin corneas.
  • Those with topographic evidence of keratoconus.
  • Subjects with ectatic eye disorders.
  • Those with autoimmune diseases.
  • Pregnant or nursing.
  • Subjects without similar levels of nearsightedness in each eye (no more than 1.5 diopter difference between eyes).
  • Those with 0.75 or more diopters of astigmatism
  • Subjects without similar levels of astigmatism in each eye (no more than 0.50 diopters of difference between eyes).

 

Location

Those interested may participate in this study at Byers Eye Institute at Stanford in Palo Alto, California, 94303. Feel free to contact Edward E Manche, MD at 650-498-7020 with any questions or concerns.

 

Sponsors/Collaborators

This clinical trial is sponsored by Stanford University. The Principal Investigator is Edward E. Manche.

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