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

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

Detailed Description
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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.

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

Conditions
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Myopia

Intervention / Treatment
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* Procedure: SMILE
* Procedure: LASIK


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SMILE<br>SMILE surgery | Procedure: SMILE<br>* SMILE surgery<br>Procedure: LASIK<br>* LASIK surgery<br>|
| Active Comparator: Wavefront-guided LASIK<br>Wavefront-guided LASIK | Procedure: SMILE<br>* SMILE surgery<br>Procedure: LASIK<br>* LASIK surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better | 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 | ETDRS testing lane | One year | 
| Aberrometry Measurements | Increase in total higher order RMS (root mean squared) by greater than 0.5 microns | One year | 
| Patient Satisfaction | Percentage of patients satisfied with surgery. Patients were asked yes or no. | One year | 
| Change in Corneal Sensation | 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 | 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 | Participant eyes with an increase in astigmatism of greater than 1.0 diopter | One year | 
| Anterior Segment Ocular Coherence Topography Analysis | Humphrey Visante AS OCT | One year | 
| Predictability | Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction | One year | 
| Stability | Change in refractive error greater than one diopter over 1 to 12 months | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, SMILE, LASIK, Wavefront-guided