LASIK Using Contoura With Phorcides vs. iDesign
- Conditions
- MyopiaAstigmatism
- Registration Number
- NCT07128316
- Lead Sponsor
- 59th Medical Wing
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 63
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 6-month Post-Op 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 Outcome Measures
Name Time Method Change in high contrast visual acuity at 6-month Post-Op 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.
Change in refractive error at 6-month Post-Op 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.
Trial Locations
- Locations (1)
Joint Warfighter Refractive Surgery Center at WHASC
🇺🇸San Antonio, Texas, United States
Joint Warfighter Refractive Surgery Center at WHASC🇺🇸San Antonio, Texas, United States