Clinical trial NCT03067077: A Prospective, Contralateral, Eye to Eye Comparison of SMILE Surgery to LASIK Surgery
Official title: A Prospective, Randomized Comparison of SMILE Surgery to Wavefront-guided LASIK Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: SMILE
LASIK
Myopia
Wavefront-guided
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 44
Sex: ALL
Minimum age (years): 22
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better
timeFrame: One year
Secondary outcomes:
measure: Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity
timeFrame: One year
measure: Aberrometry Measurements
timeFrame: One year
measure: Patient Satisfaction
timeFrame: One year
measure: Change in Corneal Sensation
timeFrame: One year
measure: Dry Eye Symptoms as Measured by OSDI Index
timeFrame: One year
measure: Analysis of Astigmatism
timeFrame: One year
measure: Anterior Segment Ocular Coherence Topography Analysis
timeFrame: One year
measure: Predictability
timeFrame: One year
measure: Stability
timeFrame: One year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford
state: California
Study officials:
affiliation: Stanford University
name: Edward E Manche, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiang B, Valerio GS, Manche EE. Prospective, Randomized Contralateral Eye Comparison of Wavefront-Guided Laser In Situ Keratomileusis and Small Incision Lenticule Extraction Refractive Surgeries. Am J Ophthalmol. 2022 May;237:211-220. doi: 10.1016/j.ajo.2021.11.013. Epub 2021 Nov 14.