Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage: a Randomized Clinical Trial Comparing Treatment Amount
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Postoperative Vitreous Hemorrhage
研究概览
简要总结
In this randomized clinical trial, the authors compare two cohorts receiving different endolaser spot amounts with similar laser settings in PDR subjects naïve to PRP undergoing PPV for the indication of VH.
详细描述
Enrolled patients will be randomized into 1 of 2 possible treatment groups: Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV, whereas Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV. Simple randomization will allocate subjects into treatment groups during PPV. Once all applicable maneuvers (including satisfactory hemostasis) are completed by the surgeon apart from endolaser PRP, a coin toss simulation program will randomize subjects into treatment groups.
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, Care Provider)
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
- •The subject has type I or II diabetes mellitus
- •The age of the subject is > 18 years old
- •Snellen best-corrected visual acuity ranges from 20/40 to hand motions at one foot in the research eye
- •Proliferative diabetic retinopathy with a vitreous hemorrhage is present in the research eye, and the vitreous hemorrhage is considered to be the primary cause for the subject's reduced vision
- •The subject is panretinal photocoagulation-naïve
- •The vitreoretinal adhesion is Grade 0 or 1 according to the classification system published by Ahn et al in the research eye
排除标准
- •The research eye had formerly undergone anterior or posterior vitrectomy.
- •An opacity of the anterior segment (cornea or lens) is thought to be responsible for two or more lines of decreased visual acuity in the research eye (cataract, corneal scar, ectasia, etc.)
- •Optic nerve or retina disease unconnected to diabetes mellitus is thought to be responsible for two or more lines of decreased visual acuity in the research eye (optic neuritis, macular degeneration, glaucoma, etc.)
- •Amblyopia or a non-ocular source (i.e., cerebrovascular accident) is considered to be responsible for two or more lines of decreased visual acuity in the research eye
- •Neovascular glaucoma with an elevated intraocular pressure (> 30 mm Hg) is present in the research eye
- •Uncontrolled systemic hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) is present
结局指标
主要结局
Postoperative Vitreous Hemorrhage
时间窗: 6 months
The primary outcome measure of the trial was the incidence of postoperative VH during the 6-month trial period between treatment groups
次要结局
- Postoperative LogMAR visual acuity(6 months)