A Prospective Contralateral Comparison of Ray-Tracing Guided LASIK (WaveLight® Plus LASIK) vs. Small Incision Lenticule Extraction (SMILE® Pro) Using VisuMax® 800, or Wavefront Optimized LASIK or Topography Guided LASIK (Contoura LASIK): A Three-Phase Visual Outcomes Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Uncorrected Visual Acuity
研究概览
简要总结
This purpose of this study is to compare a new form of LASIK called Ray Tracing Guided LASIK to 3 other forms of corneal refractive surgery: 1. KLEx (KeratoLenticule Extraction) using the Zeiss Visumax 800 Laser, 2. WFO LASIK (Wavefront Optimized LASIK) using the Alcon EX500 Laser, and 3. Topography Guided LASIK (Contoura LASIK) also using the Alcon EX500 Laser.
详细描述
This is a prospective, randomized, simultaneous, contralateral eye study comparing visual outcomes for 4 different refractive technologies. This study will be conducted in 3 phases. Each phase will include at least 44 subjects undergoing refractive correction surgery for myopia or myopia with astigmatism. Each phase will compare Ray-Tracing LASIK to 1 of 3 other forms of corneal refractive surgery. The Phase 1 comparator will be KLEx (KeratoLenticule Extraction) using the Zeiss Visumax 800 Laser. The Phase 2 comparator will be WFO LASIK (Wavefront Optimized LASIK) using the Alcon EX500 Laser. The Phase 3 comparator will be Topography Guided LASIK (Contoura LASIK) also using the Alcon EX500 Laser. Patients will be selected from the Hoopes Vision patient population after a preliminary refractive evaluation has been completed. Patients who express an interest in the study will be consented. After informed consent has been obtained and the patient has completed a screening exam and met all study criteria they will be considered enrolled. For each Phase, randomization will ensure 50% of Right Eyes will receive Ray-Tracing LASIK and 50% of Right Eyes will receive the other comparator procedure. Subjects will be given postoperative care instructions and medications following standard of care practices. Subjects will return for a 1-day, 1-week, 1-month, 3-month, 6-month, and 12-month visit. Retreatments may only occur after all postoperative study visits have been completed and/or the subject has exited the study. At the preliminary screening visit, 1-month, 3-month, 6-month and 12-mont postoperative visits, patients will complete a Patient Participant Questionnaire.
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
- 22 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 22-50 at the time of consent
- •Diagnosis of myopia or myopia with astigmatism with Preoperative manifest spherical equivalent refraction of ≥ -2.00 and ≤ -9.00 D (-2.00 D through -9.00 D)
- •Preop Spherical component of ≥ -2.00 and ≤ -8.00 D (-2.00 D through -8.00 D)
- •Refractive Cylinder of ≤ -3.00 D (0.00 through -3.00 D)
- •BCVA of 20/20 or better in each eye (83 or more letters on the ETDRS Chart)
- •Subjects must have a stable refraction which is defined as a change in spherical equivalent no greater than 0.50 D comparing the screening visit manifest refraction to a previous refraction, spectacle Rx, or contact lens Rx, 12 months or older.
- •Subjects who are contact lens wearers must discontinue the use of soft lenses (spherical or toric) for at least 5 days and hard or gas-permeable lenses for at least 4 weeks prior to the preoperative screening evaluation. Hard or gas-permeable lens wearers must not return to contact lens use before surgery. Soft lens wearers may resume contact lens wear after all preoperative testing is completed, but must discontinue lens use at least 5 days before surgery.
- •Acceptable preoperative tomography and examination results for refractive procedures as determined by the Principal Investigator.
- •Surgical plan includes treatment target for emmetropia in both eyes, and no monovision.
- •Subject is capable and willing to use postoperative medications as prescribed.
- •Subject has ability to successfully complete all preoperative and postoperative questionnaires, testing, and exam visits.
- •Subject is willing and able to return for all postoperative examinations.
排除标准
- •Clinically significant dry eye on clinical examination, as determined by the investigator
- •Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal tomography
- •History of corneal dystrophies or guttata
- •History of herpetic keratitis or active disease
- •History of prior refractive surgery
- •History of glaucoma or glaucoma suspect
- •History of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease.
- •Females who are pregnant, breastfeeding, or intend to become pregnant any time during the study as determined by verbal inquiry.
- •The Principal Investigator has determined the subject not to be a good candidate for the study.
结局指标
主要结局
Uncorrected Visual Acuity
时间窗: 3, 6 and 12 month
Percentage of eyes acheiving uncorrected visual acuity of 20/40, 20/25, 20/20, 20/16, 20/12.5, and 20/10 at post-operative month 3, 6 and 12
次要结局
- Predictability(3, 6, and 12 months)