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

Stanford University44 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia

Interventions

SMILEPROCEDURE

SMILE surgery

LASIKPROCEDURE

LASIK surgery

Eligibility

Sex: ALLMin age: 22 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Byers Eye Institute at Stanford

Palo Alto, California, United States

Outcomes

Primary Outcomes

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

ETDRS testing lane

Time frame: One year

Secondary Outcomes

Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity

ETDRS testing lane

Time frame: One year

Aberrometry Measurements

Increase in total higher order RMS (root mean squared) by greater than 0.5 microns

Time frame: One year

Patient Satisfaction

Percentage of patients satisfied with surgery. Patients were asked yes or no.

Time frame: One year

Change in Corneal Sensation

A decrease in corneal sensation of more than 4 cm as measured by Cochet-Bonnet Aesthesiometry

Time frame: One year

Dry Eye Symptoms as Measured by OSDI Index

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.

Time frame: One year

Analysis of Astigmatism

Participant eyes with an increase in astigmatism of greater than 1.0 diopter

Time frame: One year

Anterior Segment Ocular Coherence Topography Analysis

Humphrey Visante AS OCT

Data from ClinicalTrials.gov

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