LASIK Using Contoura With Phorcides vs. iDesign

NCT07128316 | Active Not Recruiting FDA Device

• 2 other identifiers: C.2023.097FWH20230084H
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Participants will undergo LASIK using Contoura with Phorcides calculation on one eye and LASIK using iDesign calculation on the contralateral eye to correct myopia.

Conditions

Myopia; Astigmatism

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

  Change 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

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

Study Arms (2)

LASIK using Contoura with Phorcides

ACTIVE COMPARATOR

Alcon VISX Star S4 IR LASIK ablation calculation using Contoura with Phorcides

Device: Contoura Topolyzer with Phorcides

LASIK using iDesign

ACTIVE COMPARATOR

Alcon VISX Star S4 IR LASIK ablation calculation using iDesign Refractive Studio 2.0

Device: iDesign

Interventions

Contoura Topolyzer with Phorcides DEVICE

LASIK calculated ablation using Contoura Topolyzer with Phorcides

LASIK using Contoura with Phorcides

iDesign DEVICE

LASIK calculated ablation using iDesign Refractive Studio 2.0

LASIK using iDesign

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 -9.0 D
• Tricare Prime or Tricare Select 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 of corneal stroma from the corneal endothelium.
• Subjects with 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.
• Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases
• Pregnant or nursing females
• Systemic disease likely to affect wound healing, such as diabetes and severe atopy
• 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

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Samantha B Rodgers, MD

  59th Medical Wing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a prospective randomized double blind contralateral study. The patient and the staff doing the post-op evaluations will be blinded to which eye received which treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Prospective randomized contralateral study.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 18, 2025
• Study Start: September 11, 2023
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: August 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)