Comparison of Clinical Outcomes of SMILE vs. LASIK Using Contoura With Phorcides
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 6-month Post-Op
研究概览
简要总结
Subjects will undergo SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 6-month Post-Op
时间窗: 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
次要结局
- 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)