Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 406
- 主要终点
- Percentage of Capsular Tears (Anterior or Posterior) During Surgery
研究概览
简要总结
The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a cataract with a pressurized capsular bag.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to undergo cataract surgery.
- •Able to lie flat in a supine position.
- •Able to understand and willing to sign the Informed Consent Form (ICF).
- •Presenting with intumescent white cataract, with a liquid pressurized bag and a milky, liquid cortex.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Pregnant or lactating mothers.
- •Corneal disease that precludes application of the cornea or transmission of laser light at 1030 nanometer (nm) wavelength.
- •Corneal opacity that would interfere with the laser beam.
- •Presence of blood or other material in the anterior chamber.
- •Hypotony or presence of corneal implant.
- •Poorly dilating pupils.
- •Condition which would cause inadequate clearance between the intended capsulotomy depth and the endothelium.
- •Residual, recurrent, active ocular or eye lid disease, including any corneal abnormality.
- •Any contraindication to cataract surgery.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Laser
Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
干预措施: Femtosecond laser (Device)
Manual
Continuous curvilinear capsulorhexis performed during cataract surgery
干预措施: Continuous Curvilinear Capsulorhexis (CCC) (Procedure)
结局指标
主要结局
Percentage of Capsular Tears (Anterior or Posterior) During Surgery
时间窗: Day 0 (operative day)
A capsular tear is defined as any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear during intumescent cataract surgery. An intumescent cataract is defined as a cataract with a pressurized capsular bag. A lower value indicates fewer capsular tears. Only one eye (study eye) contributed to the analysis.
次要结局
- Operating Time in the Eye to Complete Entire Cataract Procedure(Day 0 (operative day))