LASIK Using Contoura With Phorcides vs. iDesign

59th Medical Wing

Status

Active, not recruiting

Conditions

Myopia

Astigmatism

Treatments

Device: iDesign

Device: Contoura Topolyzer with Phorcides

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT07128316

C.2023.097

FWH20230084H (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

63 estimated patients

Sex

All

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

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