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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03067077
Recruitment Status : Active, not recruiting
First Posted : March 1, 2017
Last Update Posted : February 10, 2020
Sponsor:
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 Phase 4

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)
Estimated Enrollment : 45 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
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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. Uncorrected visual acuity [ Time Frame: One year ]
    ETDRS testing lane


Secondary Outcome Measures :
  1. Change in CDVA [ Time Frame: One year ]
    ETDRS testing lane

  2. Aberrometry measurements [ Time Frame: One year ]
    iDesign aberrometer

  3. Patient satisfaction with validated questionnaire [ Time Frame: One year ]
    PROWL questionnaire

  4. Change in corneal sensation [ Time Frame: One year ]
    Cochet-Bonnet Aesthesiometry

  5. Dry eye symptoms and signs [ Time Frame: One year ]
    Slit lamp examination

  6. Vector analysis of astigmatism [ Time Frame: One year ]
    Alpins method of analysis

  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 over 1 to 12 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Subjects age 22 and older with healthy eyes. Nearsightedness between -0.75 diopters and -8.00 diopters.
  • Subjects with less than 0.75 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 0.75 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


Locations
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United States, California
Byers Eye Institute at Stanford
Palo Alto, California, United States, 94303
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Edward E Manche, MD Stanford University
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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
Last Update Posted: February 10, 2020
Last Verified: February 2020
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:
SMILE
LASIK
Myopia
Wavefront-guided
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases