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临床试验/NCT04027595
NCT04027595Unknown不适用

Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy: Efficacy and Outcomes Performed by Optometrists

Northeastern State University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年9月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Central Visual Acuity

研究概览

简要总结

The purpose of this study is to formally assess the efficacy and outcomes of optometrist-performed neodymium-doped yttrium aluminum garnet (Nd: YAG) laser capsulotomy procedures.

详细描述

Participants will undergo a pre-procedure examination to establish baseline findings and to determine if they meet the inclusion criteria. Participants will undergo the Nd: YAG laser capsulotomy procedure and will be examined at 1 hour, 1 day (if necessary), 1 week, 1 month, and 3 months following the procedure. Follow-up examinations will evaluate visual acuity improvement and possible post-procedure complications. The complication rate following the laser capsulotomy procedure is typically minimal.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Ability to provide written informed consent;
  • At least 18 years of age, male or female;
  • Prior cataract surgery;
  • Diagnosed with posterior capsule opacification obstructing vision;
  • Best-corrected visual acuity less than 20/40 or visual acuity with glare that reduces by 2 lines or more on an ETDRS visual acuity chart or significant effect on activities of daily living

排除标准

  • History of underlying ocular disease (not including mild/moderate non-proliferative diabetic retinopathy or incidental findings)
  • Previous myopic refractive error greater than 6.00 diopters
  • Complications following previous ocular procedures (i.e. intraocular lens decentration)
  • Ocular surgery other than uncomplicated cataract or uncomplicated refractive surgery

结局指标

主要结局

Central Visual Acuity

时间窗: 3 months

Pre and Post Procedure Visual Acuity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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