To Compare the Ability of DiscoVisc® Ophthalmic Viscosurgical Device (OVD) to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Endothelial Cell Count Change From Baseline
研究概览
简要总结
The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
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
- •Patients able to understand and sign a document of informed consent;
- •Patients aged ≥49 years with age-related cataract formation;
- •Patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens;
- •Patients that have healthy eyes excluding the formation of cataract.
排除标准
- •pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye;
- •A congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye;
- •Iris atrophy in the operative eye;
- •Glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye;
- •Any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye;
- •Ocular hypertension (lntraocular Pressure (IOP) > 21 mmHg) in the operative eye at the baseline exam;
- •Corneal abnormality that results in a poor endothelial cell photograph and prevents reliable endothelial cell density measurement;
- •Baseline endothelial cell density < 1500 cells/mm2, in the operative eye;
- •Planned multiple procedures during cataract/Intraocular Lens (IOL) implantation surgery (e.g., trabeculoplasty, corneal transplant). NOTE: A minor relaxing keratotomy
- •Patients 48 years of age or younger;
- •Proliferative diabetic retinopathy in the operative eye;
- •Uncontrolled diabetes mellitus;
- •Marfan's Syndrome;
- •An ocular disease and/or condition that may compromise results;
- •A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the operative eye;
- •Lens for the correction of astigmatism may be performed;
- •Previous ocular trauma to the operative eye (this includes previous intraocular surgery and traumatic cataract). NOTE: history of non-invasive laser surgery (with the exception of laser treatment for PDR) is acceptable for inclusion;
- •A non-functional fellow eye;
- •Participation in any other clinical study within the 30 days before surgery
研究组 & 干预措施
Healon
Healon
干预措施: Healon (Drug)
DisCoVisc®
DisCoVisc® Ophthalmic Viscosurgical Device
干预措施: DisCoVisc® (Device)
Amvisc Plus
Amvisc Plus
干预措施: Amvisc Plus (Drug)
结局指标
主要结局
Endothelial Cell Count Change From Baseline
时间窗: one month
Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.
Investigator Reported Space Maintenance
时间窗: During surgical procedure
Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion.
次要结局
- Change in Corneal Thickness(1 month)
- Corneal Clarity(2 weeks)