Astigmatism, Myopia
Conditions
Keywords
SMILE, LASIK, Countoura, Phorcides
Brief summary
Subjects will undergo SMILE surgery in one eye and LASIK using Contoura with Phorcides 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 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.
Interventions
LASIK Refractive Surgery Using Contura with Phorcides
DEVICEVisuMax Surgical Laser
SMILE Refractive Surgery
Sponsors
59th Medical Wing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective randomized contralateral study.
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in low contrast visual acuity at 6-month Post-Op | 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. |
| Change in mean score Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire at 6-month Post-Op | 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. |
| Change in higher order aberrations at 6-month Post-Op | 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. |
| Change in mean score Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire at 6-month Post-Op | 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. |
Countries
United States
Outcome results
None listed