Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients With Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Endothelial cell density
研究概览
简要总结
This study examines the use of Trypan Blue staining of the corneal endothelium in patients undergoing phacoemulsification. It is a single-center prospective, randomized individual cohort study. One eye in each patient with diabetic retinopathy will undergo phacoemulsification without Trypan Blue capsule staining (control eye) while the other eye will undergo phacoemulsification with Trypan Blue capsule staining (study eye). Both eyes will undergo intraocular lens implantation. Preoperative and four-week postoperative quantitative and qualitative morphometric endothelial cell analyses of the cornea will be performed using noncontact specular microscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Randomization was done using an envelope technique wherein, after each patient was placed on the operating bed, the surgeon opened the patient's corresponding envelope, which contained information about whether Trypan Blue should be used for anterior capsular staining or not.
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bilateral cataract and diabetic retinopathy
排除标准
- •History of ocular surgery Active
- •ocular inflammation Corneal opacities
- •Pseudoexfoliation syndrome
- •Anterior chamber flare and (or) other signs of possibly altered blood - queous barrier
- •Iris neovascularization (rubeosis)
- •Uncontrolled glaucoma
- •Congenital or traumatic cataracts
- •History or present chronic use of topical or systemic steroids
- •Poor papillary dilatation (<6 mm)
- •Specular microscopy cell density < 2000 cell/mm2
- •Patients who experienced complications fromphacoemulsification
结局指标
主要结局
Endothelial cell density
时间窗: 4 weeks
次要结局
- Endothelial cell coefficient of variation(4 weeks)
- Percent of hexagonal cells(4 weeks)
- Mean corneal thickness(4 weeks)
研究者
Khaled Abdelazeem
Lecturer of Ophthalmology
Assiut University