Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Mean Change in Intraocular Pressure (IOP) on Operative Day
研究概览
简要总结
The purpose of this study is to compare the treatment day change between immediate postoperative and immediate preoperative intraocular pressure (IOP) between 27-gauge and 23-gauge vitrectomy instruments.
详细描述
Required follow-up for this study is 3 months post treatment.
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 (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent and attend all required study visits;
- •Requires vitrectomy in at least one eye;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Previous vitrectomy or glaucoma surgery;
- •Planned treatment requires scleral buckling, combined procedures (eg, cataract surgery), silicone oil, and expansive gas other than sterile air;
- •Treated with topical IOP lowering medication(s) at any time from baseline assessment to time of surgery;
- •Pregnant or planning to become pregnant during the course of the trial;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
27-gauge pak
CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
干预措施: CONSTELLATION® 27-gauge Combined Surgical Pak (Device)
27-gauge pak
CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
干预措施: Vitrectomy surgery (Procedure)
23-gauge pak
CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
干预措施: CONSTELLATION® 23-gauge Combined Surgical Pak (Device)
23-gauge pak
CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
干预措施: Vitrectomy surgery (Procedure)
结局指标
主要结局
Mean Change in Intraocular Pressure (IOP) on Operative Day
时间窗: Day 0 preoperative, Day 0 postoperative
IOP (fluid pressure inside the eye) was assessed using the study specified tono-pen and measured in millimeters of mercury (mmHg). Change was defined as the difference between immediate postoperative IOP and immediate preoperative IOP. A greater change in IOP may indicate a less stable posterior chamber and/or a more invasive surgery.
次要结局
- Mean Post-operative Pain Rating at Day 1(Day 1 post operative)
- Mean Conjunctival Edema Score at Week 1(Week 1 post operative)