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临床试验/NCT07176416
NCT07176416招募中不适用

Assessment of Effective Phaco Time and Endothelial Cell Loss When Using a Novel Dual Mode Phacoemulsification System

Aloha Vision Consultants1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月3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
50
试验地点
1
主要终点
Effective phaco time per phacoemulsification procedure

研究概览

简要总结

This study is a single center, prospective study of cumulative dissipated energy and endothelial cells loss per phacoemulsification procedure after successful cataract surgery. Subjects will be assessed 3 months postoperatively at a single visit. Clinical evaluations will include central corneal thickness, specular microscopy, as well as measurement of visual acuities at distance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Adult patients undergoing age-related cataract surgery.
  • Planned use of the Catalys Precision Laser System.
  • Planned implantation of TECNIS intraocular lenses (IOLs).

排除标准

  • Moderate-severe any disease state (deemed by the surgeon) that could increase risk of complicated cataract surgery (ie, pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, and prior refractive surgery).

结局指标

主要结局

Effective phaco time per phacoemulsification procedure

时间窗: Surgery (Day 0)

次要结局

  • Endothelial cell loss(1 monthspostoperatively)
  • Total case time(Surgery (Day 0))
  • Total phaco time(Surgery (Day 0))
  • Total volume used(Surgery (Day 0))

研究者

发起方
Aloha Vision Consultants
申办方类型
Other
责任方
Sponsor

研究点 (1)

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