SMILE vs. LASIK Using Contoura With Phorcides

59th Medical Wing

Status: Completed

Conditions: Myopia; Astigmatism

Treatments: Device: WaveLight EX500 Excimer Laser System; Device: VisuMax Surgical Laser

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05844397

C.2023.052

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

LASIK using Contoura with Phorcides

Active Comparator group

Description:

LASIK using Contoura with Phorcides in one eye.

Treatment:

Device: WaveLight EX500 Excimer Laser System

SMILE

Active Comparator group

Description:

small incision lenticule extraction (SMILE) refractive surgery on the contralateral eye.

Treatment:

Device: VisuMax Surgical Laser