SMILE vs. LASIK Using Contoura With Phorcides

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

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

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: WaveLight EX500 Excimer Laser System; Device: VisuMax Surgical Laser

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78236
      • Joint Warfighter Refractive Surgery Center at WHASC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in low contrast visual acuity at 6-month Post-Op	Change in the mean low contrast visual acuity (unit = logMAR) measure with ETDRS 5% chart from baseline (pre-op) at 6 months post-op.	Change from baseline (pre-op) to 6-month Post-Op
Change in higher order aberrations at 6-month Post-Op	Change in the mean higher order aberrations (unit = root mean square) measure with iDesign 2.0 Refractive Studio from baseline (pre-op) at 6 months post-op.	Changes from baseline (pre-op) to 6-month Post-Op
Change in mean score Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire at 6-month Post-Op	The PROWL-SS is a validated tool to assess self-reported symptoms and satisfaction after refractive surgery. Possible Satisfaction Score ranges from 1 (completely satisfied) to 6 (completely dissatisfied). Lower value indicates higher satisfaction. Possible Symptoms Score ranges from 1 (extremely bothersome) to 5 (not at all bothersome). Lower value indicates worse symptoms.	Changes from baseline (pre-op) to 6-month Post-Op
Change in mean score Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire at 6-month Post-Op	The SPEED is a validated tool to assess self-reported dry eye symptoms. Possible dry eye symptoms score ranges from 0 (never) to 3 (Constant). Higher value indicates worse dry eye symptoms.	Changes from baseline (pre-op) to 6-month Post-Op

Collaborators and Investigators

• Sponsor: 59th Medical Wing
• Investigators: Principal Investigator: CHARISMA B EVANGELISTA, MD, 59th Medical Wing

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Actual): May 14, 2024
• Study Completion (Actual): May 14, 2024

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: SMILE; LASIK; Countoura; Phorcides
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: C.2023.052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No