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OpenTrials
Completed

NCT Number: NCT05844397

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.

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joint Warfighter Refractive Surgery Center at WHASC

San Antonio, Texas, 78236, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WaveLight EX500 Excimer Laser System

Device

LASIK Refractive Surgery Using Contura with Phorcides

VisuMax Surgical Laser

Device

SMILE Refractive Surgery

Primary outcomes

  1. Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 6-month Post-Op

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Change in refractive error at 6-month Post-Op

    Time frame: 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.

Other outcomes

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

    Time frame: Change from baseline (pre-op) to 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.

  2. Change in higher order aberrations at 6-month Post-Op

    Time frame: Changes from baseline (pre-op) to 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.

  3. Change in mean score Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire at 6-month Post-Op

    Time frame: Changes from baseline (pre-op) to 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.

  4. Change in mean score Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire at 6-month Post-Op

    Time frame: Changes from baseline (pre-op) to 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.

Sponsors and collaborators

Lead sponsor

59th Medical Wing

Fed

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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