SMILE vs. LASIK Using Contoura With Phorcides

Study Overview
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Brief Summary
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Subjects will undergo SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.

Detailed Description
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Once consented to participate in the study, subjects will have a comprehensive ocular examination to determine eligibility to undergo simultaneous SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.The study objective is to compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, high order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using Contoura with Phorcides and SMILE surgery. Surgical treatment will be randomized so there is a 50% chance to receive SMILE on the right eye and LASIK on the contralateral eye. Subjects will receive standard of care topical ophthalmic antibiotic and steroid drops. Visual outcomes and patient self-reported symptoms will be assessed at week 2, month 1, month 3, and month 6.

Official Title
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Comparison of Clinical Outcomes of SMILE vs. LASIK Using Contoura With Phorcides

Conditions
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Myopia, Astigmatism

Intervention / Treatment
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* Device: WaveLight EX500 Excimer Laser System
* Device: VisuMax Surgical Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Females between the ages of 21 and 50 Nearsightedness between -2.00 diopters and -8.00 diopters Have similar levels of nearsightedness in each eye (≤1.5D of difference between eyes) Less than or equal to 3.00 diopters of astigmatism Have similar levels of astigmatism in each eye (≤0.75D of difference between eyes) Total spherical equivalent (SE) of no more than -8.0 D Tricare Prime Beneficiary Residing within 60 miles radius from Lackland AFB Exclusion Criteria: Subjects with corneal abnormal findings including signs of keratoconus, keratoconus suspect, abnormal corneal topography, epithelial basement membrane disease, pellucid marginal degeneration, corneal degenerations, progressive and unstable myopia, irregular or unstable corneal mires on central keratometry images, and patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma from the corneal endothelium. Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases Pregnant or nursing females Systemic disease likely to affect wound healing, such as uncontrolled diabetes and severe atopy Any ocular disease such as advanced/uncontrolled glaucoma, severe dry eye, active eye infection or inflammation, recent herpes eye infection or problems resulting from past infection. 0.25 or 0.50 of manifest astigmatism in either eye Taking the medication Isotretinoin (Accutane) or antimetabolites for any medical condition.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Prospective randomized contralateral study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LASIK using Contoura with Phorcides<br>LASIK using Contoura with Phorcides in one eye. | Device: WaveLight EX500 Excimer Laser System<br>* LASIK Refractive Surgery Using Contura with Phorcides<br>|
| Active Comparator: SMILE<br>small incision lenticule extraction (SMILE) refractive surgery on the contralateral eye. | Device: VisuMax Surgical Laser<br>* SMILE Refractive Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 6-month Post-Op | Post-operative uncorrected visual acuity of 20/16 or better measure with ETDRS chart; unit = percentage eyes with Uncorrected Visual Acuity | 6-month Post-Op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in high contrast visual acuity at 6-month Post-Op | Change in the mean uncorrected visual acuity (unit = logMAR) measure with ETDRS chart from baseline (pre-op) at 6 months post-op. | Change from baseline (pre-op) to 6-month Post-Op | 
| Change in refractive error at 6-month Post-Op | Change in the mean refractive error measure with phoropter (unit = diopters) from baseline (pre-op) at 6 months post-op. | Change from baseline (pre-op) to 6-month Post-Op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMILE, LASIK, Countoura, Phorcides