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A Prospective, Contralateral, Eye to Eye Comparison of SMILE Surgery to LASIK Surgery

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ClinicalTrials.gov Identifier: NCT03067077
Recruitment Status : Completed
First Posted : March 1, 2017
Results First Posted : February 2, 2022
Last Update Posted : February 2, 2022
Information provided by (Responsible Party):
Edward E. Manche, Stanford University

Brief Summary:
Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to correct myopia.

Condition or disease Intervention/treatment Phase
Myopia Procedure: SMILE Procedure: LASIK Not Applicable

Detailed Description:
Subjects will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the subject from the study, then we will inform the patient and make an appropriate referral. if the subject is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. Subjects will undergo bilateral simultaneous eye surgery. Which eye is treated with the WFG-LASIK and which eye is treated with SMILE will be randomized so there is a 50% chance for either eye to receive one treatment. Subjects will be seen on the day of surgery, post op day one, one week, one month, three months, six months and one year. Subjects will receive topical antibiotics in each eye for one week following the procedure. Subjects will receive topical steroid ophthalmic drops for one week after treatment. Subjects will also receive topical antibiotic ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of subjects undergoing LASIK and SMILE surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Comparison of SMILE Surgery to Wavefront-guided LASIK Surgery
Actual Study Start Date : March 12, 2017
Actual Primary Completion Date : March 15, 2021
Actual Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: SMILE
SMILE surgery
Procedure: SMILE
SMILE surgery

Procedure: LASIK
LASIK surgery

Active Comparator: Wavefront-guided LASIK
Wavefront-guided LASIK
Procedure: SMILE
SMILE surgery

Procedure: LASIK
LASIK surgery

Primary Outcome Measures :
  1. Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better [ Time Frame: One year ]
    ETDRS testing lane

Secondary Outcome Measures :
  1. Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity [ Time Frame: One year ]
    ETDRS testing lane

  2. Aberrometry Measurements [ Time Frame: One year ]
    Increase in total higher order RMS (root mean squared) by greater than 0.5 microns

  3. Patient Satisfaction [ Time Frame: One year ]
    Percentage of patients satisfied with surgery. Patients were asked yes or no.

  4. Change in Corneal Sensation [ Time Frame: One year ]
    A decrease in corneal sensation of more than 4 cm as measured by Cochet-Bonnet Aesthesiometry

  5. Dry Eye Symptoms as Measured by OSDI Index [ Time Frame: One year ]
    Worsening of ocular surface disease index (OSDI) score of greater than 25. The overall OSDI score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.

  6. Analysis of Astigmatism [ Time Frame: One year ]
    Participant eyes with an increase in astigmatism of greater than 1.0 diopter

  7. Anterior Segment Ocular Coherence Topography Analysis [ Time Frame: One year ]
    Humphrey Visante AS OCT

  8. Predictability [ Time Frame: One year ]
    Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction

  9. Stability [ Time Frame: One year ]
    Change in refractive error greater than one diopter over 1 to 12 months

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects age 22 and older with healthy eyes. Nearsightedness between -0.75 diopters and -8.00 diopters.
  • Subjects with up to 3.00 diopters of astigmatism.

Exclusion Criteria:

  • Subjects under the age of 22.
  • Subjects with excessively thin corneas.
  • Subjects with topographic evidence of keratoconus.
  • Subjects with ectatic eye disorders.
  • Subjects with autoimmune diseases.
  • Subjects who are pregnant or nursing.
  • Subjects must have similar levels of nearsightedness in each eye. They can not be more than 1.5 diopter of difference between eyes.
  • Subjects with 3.25 or more diopters of astigmatism
  • Subjects must have similar levels of astigmatism in each eye. They can not have more than 0.50 diopters of difference between eyes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067077

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United States, California
Byers Eye Institute at Stanford
Palo Alto, California, United States, 94303
Sponsors and Collaborators
Stanford University
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Principal Investigator: Edward E Manche, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Edward E. Manche, Stanford University:
Study Protocol  [PDF] October 6, 2020
No Statistical Analysis Plan (SAP) exists for this study.

Publications of Results:
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Responsible Party: Edward E. Manche, Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT03067077    
Other Study ID Numbers: 39587
First Posted: March 1, 2017    Key Record Dates
Results First Posted: February 2, 2022
Last Update Posted: February 2, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Edward E. Manche, Stanford University:
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases