SMILE vs. LASIK Using Contoura With Phorcides

NCT ID: NCT05844397

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2024-05-14

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.

Conditions

Myopia; Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LASIK using Contoura with Phorcides

LASIK using Contoura with Phorcides in one eye.

Group Type: ACTIVE_COMPARATOR

WaveLight EX500 Excimer Laser System

Intervention Type: DEVICE

LASIK Refractive Surgery Using Contura with Phorcides

SMILE

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

Group Type: ACTIVE_COMPARATOR

VisuMax Surgical Laser

Intervention Type: DEVICE

SMILE Refractive Surgery

Interventions

WaveLight EX500 Excimer Laser System

LASIK Refractive Surgery Using Contura with Phorcides

Intervention Type: DEVICE

VisuMax Surgical Laser

SMILE Refractive Surgery

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

59th Medical Wing

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charisma B Evangelista, MD

Role: PRINCIPAL_INVESTIGATOR

59th Medical Wing

Locations

Joint Warfighter Refractive Surgery Center at WHASC

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 36539217 (View on PubMed)

Other Identifiers

C.2023.052

Identifier Type: -

Identifier Source: org_study_id