Analysis of Initial Clinical Outcomes and Performance in Lenticule Extraction with SMILE Pro Performed by Refractive Surgeons Training in SMILE Pro Using the VISUMAX 800
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- post op uncorrected visual acuity
研究概览
简要总结
The Lenticule Extraction procedure is technically more challenging compared to LASIK, primarily due to the higher surgical skills required for manual docking, precise centration, laser energy optimization, and the smooth, complication-free extraction of the corneal refractive lenticule. These requirements underscore the need for meticulous surgical planning and execution.
Several surgical challenges have been reported during the learning curve, including suction losses, black spots, lenticule misplacement, cap or incision tears, and lenticule retention. These data reflect the experience with SMILE using the VisuMax femtosecond laser. However, the recently introduced VISUMAX 800 femtosecond laser (Carl Zeiss Meditec, Jena, Germany) offers several significant advancements over its predecessor. Key improvements include a much faster 2-megahertz laser frequency, a centration aid (CentraLign), a cyclotorsion alignment feature (OcuLign), separate laser and microscope arms, and a heads-up docking mechanism achieved by lowering the laser arm instead of raising the patient’s bed. These enhancements make the VISUMAX 800 a faster and possibly more efficient platform for performing the minimally invasive Lenticule Extraction procedure.
With these advancements, it is particularly interesting to evaluate how the VISUMAX 800 performs in the hands of refractive surgeons who are proficient in PRK and LASIK but new to Lenticule Extraction and SMILE Pro. Specifically, it would be valuable to assess whether the new features help reduce the challenges associated with the SMILE learning curve and minimize complications during initial procedures.
This observational study aims to analyze the learning curve of SMILE Pro for refractive surgeons using the VISUMAX 800 femtosecond laser. Key aspects to be evaluated include docking efficiency, laser delivery precision, lenticule dissection and removal, surgical time, and clinical outcomes. By focusing on these parameters, the study seeks to provide valuable insights into the role of advanced technology in facilitating safer and more efficient training for surgeons already skilled in laser refractive surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- All
入选标准
- •Stable refraction Myopia between -1 to -10 SE Astigmatism within 5 D Suitable topography Healthy ocular surface Healthy optic nerve and retina.
排除标准
- •severe dry eye keratoconus ocular infections pregnancy immunosuppession.
结局指标
主要结局
post op uncorrected visual acuity
时间窗: post op day 1 and 3 weeks
次要结局
- Docking time: Time from insertion of the eye speculum to laser activation (minutes). The time will be taken using a stopwatch and recorded by the same person.(- Docking success rate: Percentage of eyes achieving successful docking and challenges encountered.)
研究者
Sheetal Brar
ProSight Eye Hospital
