A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Percent Loss of Endothelial Cells
研究概览
简要总结
A comparison of the ability of DisCoVisc to that of other Opthalmic Viscosurgical Devices (OVDs) (DuoVisc®, BioVisc®, Healon5®, or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 49 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral operable cataracts
排除标准
- •Preoperative Endothelial Cell Count (ECC) ≤1500 cells/mm2
- •Intraocular Pressure (IOP) > 21
- •History of ocular inflammation
- •Systemic or ocular diseases affecting corneal endothelium
研究组 & 干预措施
DisCoVisc
Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
干预措施: DisCoVisc (Device)
DuoVisc
Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
干预措施: DuoVisc (Device)
BioVisc
Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
干预措施: BioVisc (Device)
Healon5
AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
干预措施: Healon5 (Device)
Amvisc Plus
Bausch & Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
干预措施: Amvisc Plus (Device)
结局指标
主要结局
Percent Loss of Endothelial Cells
时间窗: 2 months following surgery
Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope.
次要结局
- Aqueous Signs - Corneal Edema(1 day after surgery)
- Aqueous Signs - Aqueous Flare(1 day following surgery)
- Aqueous Signs - Aqueous Cells(1 day following surgery)
- Intraocular Pressure (IOP)(1 day following surgery)
- Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy(Time of Surgery)
- Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification(Time of Surgery)
- Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion(Time of Surgery)