NCT05888337终止不适用
Comparison of Contoura Vision Outcomes Programmed Using the Manifest Refraction Verses Using Phorcides Planning Software in Patients With Oblique Astigmatism
Bismarck Lasik1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2023年6月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Percentage of eyes with monocular UDVA of logMAR -0.10 (20/16) in each group
研究概览
简要总结
The objective is to compare the percentage of monocular UDVA -0.1 logMAR (20/16) outcomes for each planning strategy (Phorcides and manifest refraction) at the 3-month post operative visit.
详细描述
This study is a randomized, prospective contralateral eye study of visual outcomes in eyes planned with Phorcides compared to eyes planned using the manifest refraction after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 3 months postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and administration of a questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old and above
- •Preoperative total corneal Pachymetry 490um or above
- •BCVA 20/20 or better
- •Stable refractive error <0.50D MRSE change in preceding year
- •Good general and ocular health
- •Preoperative exam completed within three months of surgery
- •Soft contact lens wear discontinued 3 days prior to preoperative exam and the procedure
- •Residual stromal bed greater than 270um
- •Candidates who qualify for Contoura treatment OU (≤ -8.0 D SPH and ≤ -3.0 D CYL)
- •Candidates who elect to target both eyes targeted for emmetropia
- •≤ -3.0 D Oblique astigmatism as defined as an axis between 30-60 degrees or between 120-150 degrees
排除标准
- •Subjects with usual relative and absolute contraindications for LASIK surgery (subjects with severe dry eye, subjects with recurrent corneal erosion, subjects with uncontrolled Glaucoma, subjects with collagen vascular disorders, keratoconus or signs of keratoconus, Uncontrolled Diabetes, Herpes, corneal dystrophies or degeneration; any irregular astigmatism)
- •Pachymetry below 490
- •Autoimmune or immunodeficiency diseases, Pregnant or nursing women
- •Subjects with signs of inability to understand consent for study and procedure planned
- •Subjects with history of previous ocular surgery
- •The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- •Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
结局指标
主要结局
Percentage of eyes with monocular UDVA of logMAR -0.10 (20/16) in each group
时间窗: 3 months postoperatively
次要结局
- Percentage of eyes with monocular UDVA of logMAR -0.20 (20/12.5) in each group(3 months postoperatively)
研究者
研究点 (1)
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