Intraocular Lens-Shell Technique: An Adjustment of Surgical Procedure Makes Differences in Treating Dense Nucleus Cataract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Central corneal endothelial cell loss
研究概览
简要总结
In this study, the investigators introduce a surgical procedure called "IOL-shell technique" in the purpose of reduce complications of surgeries for dense cataract, and report a prospective randomized controlled study aiming at assessing efficacy and safety of the IOL-shell technique, which showed that the new procedure offered a safer way for hard cataract surgery over the conventional phacoemulsification procedure without compromise in efficacy.
详细描述
A Prospective, randomized controlled study of 80 eyes with dense nucleus were enrolled. Patients were assigned to two groups: Group I: IOL was traditionally implanted after all nuclear fragments were completely removed, while in Group II, IOL was innovatively implanted in the bag before last residual nuclear fragment was removed. This novel adjusted surgical procedure, featured by using IOL as a protective barrier (named "IOL-shell technique"), not just as a refractive alternative, was conceptual different from the traditional step-by-step procedure. Clinical examinations including uncorrected visual acuity, central corneal thickness (CCT), temporal clear corneal thickness and the corneal endothelial cell density were carried out.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50 years or above
- •Dense cataract cases were defined as eyes in which the nuclear color was graded IV or V according to the Lens Opacities Classification System III (LOCS III). Special attention was paid in selecting cases without apparent posterior cortical layer.
- •No central corneal opacification
- •Pupil diameter >= 7 mm after full pharmacological dilation in preoperative assessment
- •A preoperative central endothelial cell count of >= 1500 cells/mm2.
排除标准
- •Participants with previous intraocular surgery
- •Abnormal lens zonules
- •High myopia (>-6.0 Diopters)
- •Pseudoexfoliation
- •Diabetes mellitus
- •Those who were not able to come for follow-up visits.
结局指标
主要结局
Central corneal endothelial cell loss
时间窗: one month
Central corneal endothelial cell loss was calculated by subtracting postoperative corneal endothelial cell density from the preoperative baseline level.
次要结局
- central cornea thickness(one month)
研究者
Haotian Lin
Ophthalmologist
Sun Yat-sen University