Clinical trial NCT05844397: SMILE vs. LASIK Using Contoura With Phorcides
Official title: Comparison of Clinical Outcomes of SMILE vs. LASIK Using Contoura With Phorcides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Keywords: SMILE
LASIK
Countoura
Phorcides
Lead sponsor: 59th Medical Wing
Sponsor class: FED
First posted: 2023-05-06
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized contralateral study.
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 6-month Post-Op
timeFrame: 6-month Post-Op
Secondary outcomes:
measure: Change in high contrast visual acuity at 6-month Post-Op
timeFrame: Change from baseline (pre-op) to 6-month Post-Op
measure: Change in refractive error at 6-month Post-Op
timeFrame: Change from baseline (pre-op) to 6-month Post-Op
Other outcomes:
measure: Change in low contrast visual acuity at 6-month Post-Op
timeFrame: Change from baseline (pre-op) to 6-month Post-Op
measure: Change in higher order aberrations at 6-month Post-Op
timeFrame: Changes from baseline (pre-op) to 6-month Post-Op
measure: Change in mean score Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire at 6-month Post-Op
timeFrame: Changes from baseline (pre-op) to 6-month Post-Op
measure: Change in mean score Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire at 6-month Post-Op
timeFrame: Changes from baseline (pre-op) to 6-month Post-Op
Locations:
city: San Antonio
country: United States
facility: Joint Warfighter Refractive Surgery Center at WHASC
state: Texas
Study officials:
affiliation: 59th Medical Wing
name: Charisma B Evangelista, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma KK, Manche EE. Patient-reported quality of vision in a prospective randomized contralateral-eye trial comparing LASIK and small-incision lenticule extraction. J Cataract Refract Surg. 2023 Apr 1;49(4):348-353. doi: 10.1097/j.jcrs.0000000000001127.