SMILE vs. LASIK Using Contoura With Phorcides

Not Applicable

Completed

• Conditions: Myopia; Astigmatism
• Interventions: Device: WaveLight EX500 Excimer Laser System; Device: VisuMax Surgical Laser

• Registration Number: NCT05844397
• Lead Sponsor: 59th Medical Wing

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.

Study Timeline

• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-05-03
• Study First Posted: 2023-05-06
• Study Start: 2023-05-09
• Status Verified: 2024-03
• Primary Completion: 2024-05-14
• Study Completion: 2024-05-14
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LASIK using Contoura with Phorcides	WaveLight EX500 Excimer Laser System	LASIK using Contoura with Phorcides in one eye.
SMILE	VisuMax Surgical Laser	small incision lenticule extraction (SMILE) refractive surgery on the contralateral eye.

Primary Outcome Measures

Name	Time	Method
Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 6-month Post-Op	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

Secondary Outcome Measures

Name	Time	Method
Change in refractive error at 6-month Post-Op	Change from baseline (pre-op) to 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 in high contrast visual acuity at 6-month Post-Op	Change from baseline (pre-op) to 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.

Trial Locations

Locations (1)

Joint Warfighter Refractive Surgery Center at WHASC; 🇺🇸 San Antonio, Texas, United States