EYEFILL® C.-US Viscoelastic Clinical Investigational Protocol- For Institutional Review Boards / Ethical Review Committees and Clinical Investigators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 16
- 主要终点
- Mean Percent Cell Change (Preservation of Endothelium)
研究概览
简要总结
The purpose of this multicenter, prospective, randomized clinical study is to determine the safety and effectiveness of the EYEFILL® C.-US Viscoelastic in patients undergoing cataract extraction and intraocular lens (IOL) implantation surgery.
EYEFILL® C.-US Viscoelastic is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues, and to manipulate tissues during surgery.
EYEFILL® C.-US Viscoelastic may also be used to coat intraocular lenses and instruments during cataract extraction and intraocular lens insertion.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 21 years
- •Cataract requiring cataract extraction in at least 1 eye
- •Clear intraocular media other than cataract
- •Able to provide written informed consent
- •Able and willing to comply with required follow-up schedule
- •Competent to understand the procedure and the actions asked of him/her as a research subject
排除标准
- •Monocular
- •Ocular infection
- •History of glaucoma, Ocular Hypertension (IOP > 21 mmHg) likely to require IOP lowering medications, ocular condition requiring IOP lowering medication, condition preventing reliable Goldmann applanation tonometry, known steroid responder
- •Previous intraocular surgery in the operative eye
- •Previous serious corneal disease or known endothelial cell loss / damage (in operative eye)
- •History of chronic or recurrent inflammatory eye disease (in operative eye)
- •Evidence of retinal vascular disease (in operative eye)
- •Uncontrolled diabetes or proliferative diabetic retinopathy
- •Acute or chronic disease or illness that would increase the operative risk
- •Allergy to anesthetics or other postoperative medications
- •Known hypersensitivity to sodium hyaluronate or other components in viscoelastic
- •Patient in any other clinical trial within the 30 days prior to the start of the study
结局指标
主要结局
Mean Percent Cell Change (Preservation of Endothelium)
时间窗: Baseline, 3 months
Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.
次要结局
- Percentage of Participants With Anterior Chamber Inflammation(3 months)
- Percentage of Participants With Device-related Adverse Events Any Visit(3 months)
- Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit(3 months)