Evaluation of Staged and Combined Phacoemulsification With Intraocular Lens (IOL) Implantation and Descemet Membrane Endothelial Keratoplasty (DMEK) for Cataract Patients With Corneal Endothelial Dysfunction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline in visual acuity measured by Snellen chart
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of staged and combined phacoemulsification with intraocular lens implantation and Descemet membrane endothelial keratoplasty (DMEK) to treat cataract patients with corneal endothelial dysfunction. Surgical and postoperative complications, visual acuity and corneal endothelial cell density are evaluated.
详细描述
The prospective, randomized, controlled study involves the enrollment of cataract patients with corneal endothelial dysfunction. All the patients will be randomly assigned with equal probability to the following two groups: 1. Staged group: phacoemulsification + IOL implantation is performed individually and DMEK is performed secondarily according to the corneal status of patients. During cataract surgery, viscoelastic materials and anterior lens capsule are used to protect the compromised corneal endothelium during phacoemulsification. After phacoemulsification and removal of all the lens material, a one-piece foldable IOL is implanted into the lens capsule. 2: Combined group: phacoemulsification + IOL implantation and DMEK is performed simultaneously. Standard procedures of phacoemulsification + IOL implantation are the same as in the staged group.
Patients enrolled into the study will be followed for one year and will have study visits at 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after each surgery.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are older than 18 years.
- •Subjects have corneal endothelial dysfunction combined with cataract.
- •Subjects have mild to moderate cortical and/or nuclear cataract.
- •Subjects are able and willing to provide informed consent.
排除标准
- •Subjects have corneal stromal opacity and/or neovascularization.
- •Subjects have other intraocular disease that disturbs visual rehabilitation.
- •Subjects have corneal infection, perforation or scarring.
- •Subjects are pregnant.
- •Subjects have concurrent disease that could confound the response to therapy.
- •Subjects are unlikely to comply with the protocol or likely to be lost to follow-up.
- •Subjects have known hypersensitivity or intolerance to the proposed therapy.
- •Subjects use concomitant therapy that affects either tear function or ocular surface integrity.
- •Subjects have had surgical or other manipulation of the eye that could confound the outcome parameters or interfere with the mechanism of action of the proposed intervention to be studied.
结局指标
主要结局
Change from baseline in visual acuity measured by Snellen chart
时间窗: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Change from baseline in central corneal thickness measured by anterior segment OCT
时间窗: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Change from baseline in endothelial cell density measured by corneal specular microscopy
时间窗: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
次要结局
- Change from baseline in corneal transparency measured by slit-lamp microscopy(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery)
- Change from baseline in endothelial graft attachment measured by anterior segment OCT(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery)
研究者
Haotian Lin
M.D., Ph.D.
Sun Yat-sen University