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OpenTrials
Completed

NCT Number: NCT03067077

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

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

22 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMILE

Procedure

SMILE surgery

LASIK

Procedure

LASIK surgery

Primary outcomes

  1. Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better

    Time frame: One year

    ETDRS testing lane

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2017
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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