Phacoemulsification Combined With Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- LogMAR visual acuity 1 month postoperatively
研究概览
简要总结
This is a two-arm, parallel group, open-label, randomized controlled trial to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular opacification (PPCO).
详细描述
Primary posterior capsular opacification (PPCO) refers to the posterior capsule opacification which cannot be removed by polishing or vacuuming during cataract surgery. The surgeon may have to decide on primary posterior capsulorhexis or early neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy in these cases. The aim of this study is to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular opacification (PPCO).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract patients with primary posterior capsular opacification, which involves the central posterior capsular and interferes with visual axis;
- •Aged 18 years or over;
- •With best corrected visual acuity (BCVA) less than 0.3.
排除标准
- •History of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.
- •Cases with operative complications, including anterior or posterior capsular rupture, lens suspensory ligament rupture, the falling of lens nucleus into vitreous cavity.
- •Unwillingness to participate in the study.
研究组 & 干预措施
posterior capsulotomy
Primary posterior capsulotomy will be performed to remove the primary posterior capsule opacification after posterior capsule polishing during phacoemulsification.
干预措施: posterior capsulotomy (Procedure)
Nd:YAG laser capsulotomy
Nd:YAG laser capsulotomy will be performed 1 month postoperative to remove the primary posterior capsule opacification.
干预措施: laser capsulotomy (Procedure)
结局指标
主要结局
LogMAR visual acuity 1 month postoperatively
时间窗: 1 month
Best corrected visual acuity (LogMAR) will be measured 1 month postoperatively.
次要结局
- Modulation transfer function cut off (MTF cut off)(3 months)
- Rate of intraocular lens damage(3 months)
- Object scatter index (OSI)(3 months)
- Predicted visual acuity (PVA) with contrasts of 100%, 20% and 10%(3 months)
- Rate of retinal detachment(3 months)
- Rate of ocular hypertension(3 months)
- Rate of ocular macular edema(3 months)
- Dysfunctional lens index (DLI)(3 months)
- Internal higher order aberration (HOAs)(3 months)
- Strehl ratio (SR)(3 months)
- Visual-functioning index 7 score(3 months)
研究者
Yizhi Liu
Clinical Professor,director of Zhongshan Ophthalmic Center
Zhongshan Ophthalmic Center, Sun Yat-sen University