LASIK Using Contoura With Phorcides vs. iDesign

NCT ID: NCT07128316

Last Updated: 2025-08-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2025-12-15

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.

Detailed Description

Once consented to participate in the study, subjects will have a comprehensive ocular examination to determine eligibility to undergo LASIK using Contoura with Phorcides calculation on one eye and LASIK using iDesign calculation 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 calculation vs. LASIK using iDesign calculation. Surgical treatment will be randomized so there is a 50% chance to receive LASIK using Contoura with Phorcides vs LASIK using iDesign calculation on the contralateral eye. Subjects will receive standard of care topical ophthalmic antibiotic and steroid drops. This will be 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.

Conditions

Myopia; Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LASIK using Contoura with Phorcides

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

Group Type: ACTIVE_COMPARATOR

Contoura Topolyzer with Phorcides

Intervention Type: DEVICE

LASIK calculated ablation using Contoura Topolyzer with Phorcides

LASIK using iDesign

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

Group Type: ACTIVE_COMPARATOR

iDesign

Intervention Type: DEVICE

LASIK calculated ablation using iDesign Refractive Studio 2.0

Interventions

Contoura Topolyzer with Phorcides

LASIK calculated ablation using Contoura Topolyzer with Phorcides

Intervention Type: DEVICE

iDesign

LASIK calculated ablation using iDesign Refractive Studio 2.0

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 -9.0 D
• Tricare Prime or Tricare Select 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 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

• 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

Samantha B Rodgers, MD

Role: PRINCIPAL_INVESTIGATOR

59th Medical Wing

Locations

Joint Warfighter Refractive Surgery Center at WHASC

San Antonio, Texas, United States

Countries

United States

Other Identifiers

FWH20230084H

Identifier Type: OTHER

Identifier Source: secondary_id

C.2023.097

Identifier Type: -

Identifier Source: org_study_id