NCT05486546招募中不适用
Comparison of Visual Acuity and Quality of Life Following Contoura With Phorcides Compared to WaveLight Wavefront Optimized LASIK
Daniel Terveen6 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年8月15日最近更新:
适应症
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
- 6
- 主要终点
- Post-Op UDVA
研究概览
简要总结
Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least age 21 years of age undergoing LASIK eye surgery
- •Willing and able to comprehend informed consent and complete 1 month post-op visit
- •Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion
- •Candidates for Contoura with Phorcides (Myopic, astigmatism <3.0D)
- •Both eyes targeted for plano
- •Pre-operative total corneal Pachymetry 490um or above
- •Stable refractive error <0.50D change in preceding year
- •Good general and ocular health
- •Pre-operative exam completed within three months of surgery
- •SCL discontinued 3 days prior to pre-op exam and the procedure
- •Pachymetry above 490 with residual greater than 270um
- •Candidates who, as determined by the investigator, can safely undergo LASIK
排除标准
- •Patients under 21 years of age
- •Concomitant ocular condition which would limit the BCVA at the discretion of the surgeon
- •Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)
- •Pachymetry below 490
- •Autoimmune or immunodeficiency diseases
- •Pregnant or nursing women
- •Patients with signs of inability to understand consent for study and procedure planned
- •Patients with history of previous ocular surgery
- •Patients with strabismus or amblyopia
- •Patients that have a BCDVA of 20/25 or worse in either eye
结局指标
主要结局
Post-Op UDVA
时间窗: 3 months post-op
Percent of participants with monocular UDVA of 20/16 or better
次要结局
- Pre-op and post-op visual acuity(3 months post-op)
- Corrected Distance Visual Acuity(3 months post-op)
- Low Contrast Visual Acuity(3 months post-op)
- Post-OP BCVA(3 months post-op)
- Residual Refractive Error(3 months post-op)
研究者
Daniel Terveen
Principal Investigator
Vance Thompson Vision
研究点 (6)
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