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

January 5, 2022 updated by: Edward E. Manche, Stanford University

A Prospective, Randomized Comparison of SMILE Surgery to Wavefront-guided LASIK Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94303
        • Byers Eye Institute at Stanford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 59 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Wavefront-guided LASIK
Procedure: SMILE
SMILE surgery
Procedure: LASIK
LASIK surgery
ACTIVE_COMPARATOR: SMILE
SMILE surgery
Procedure: SMILE
SMILE surgery
Procedure: LASIK
LASIK surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better
Time Frame: One year
ETDRS testing lane
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity
Time Frame: One year
ETDRS testing lane
One year
Aberrometry Measurements
Time Frame: One year
Increase in total higher order RMS (root mean squared) by greater than 0.5 microns
One year
Patient Satisfaction
Time Frame: One year
Percentage of patients satisfied with surgery. Patients were asked yes or no.
One year
Change in Corneal Sensation
Time Frame: One year
A decrease in corneal sensation of more than 4 cm as measured by Cochet-Bonnet Aesthesiometry
One year
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.
One year
Analysis of Astigmatism
Time Frame: One year
Participant eyes with an increase in astigmatism of greater than 1.0 diopter
One year
Anterior Segment Ocular Coherence Topography Analysis
Time Frame: One year
Humphrey Visante AS OCT
One year
Predictability
Time Frame: One year
Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction
One year
Stability
Time Frame: One year
Change in refractive error greater than one diopter over 1 to 12 months
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 12, 2017

Primary Completion (ACTUAL)

March 15, 2021

Study Completion (ACTUAL)

March 15, 2021

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

February 23, 2017

First Posted (ACTUAL)

March 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39587

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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