SMILE vs. LASIK Using Contoura With Phorcides

NCT05844397 | Completed FDA Device

• 1 other identifier: C.2023.052
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia; Astigmatism

Keywords

SMILE; LASIK; Countoura; Phorcides

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in high contrast visual acuity at 6-month Post-Op

  Change from baseline (pre-op) to 6-month Post-Op

• Change in refractive error at 6-month Post-Op

  Change from baseline (pre-op) to 6-month Post-Op

Other Outcomes (4)

• Change in low contrast visual acuity at 6-month Post-Op

  Change from baseline (pre-op) to 6-month Post-Op

• Change in higher order aberrations at 6-month 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

  Changes from baseline (pre-op) to 6-month Post-Op

Study Arms (2)

LASIK using Contoura with Phorcides

ACTIVE COMPARATOR

LASIK using Contoura with Phorcides in one eye.

Device: WaveLight EX500 Excimer Laser System

SMILE

ACTIVE COMPARATOR

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

Device: VisuMax Surgical Laser

Interventions

WaveLight EX500 Excimer Laser System DEVICE

LASIK Refractive Surgery Using Contura with Phorcides

LASIK using Contoura with Phorcides

VisuMax Surgical Laser DEVICE

SMILE Refractive Surgery

SMILE

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• or 0.50 of manifest astigmatism in either eye
• Taking the medication Isotretinoin (Accutane) or antimetabolites for any medical condition.

Sponsors & Collaborators

• 59th Medical Wing: lead

Study Sites (1)

Joint Warfighter Refractive Surgery Center at WHASC

San Antonio, Texas, 78236, United States

Location

Related Publications (1)

• 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.

  PMID: 36539217 BACKGROUND

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Charisma B Evangelista, MD

  59th Medical Wing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Prospective randomized contralateral study.

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 6, 2023
• Study Start: May 9, 2023
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: February 27, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)