NCT04192630已完成不适用
A Study to Document the Safety and Effectiveness of a New Cohesive OVD When Compared to a Control OVD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 43
- 主要终点
- Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days)
研究概览
简要总结
The objective of the study is to evaluate the safety and effectiveness of the Bausch & Lomb CVisc50 cohesive OVD compared to the Alcon ProVisc® cohesive OVD when used in cataract surgery.
详细描述
The objective of the study is to evaluate the safety and effectiveness of the Bausch & Lomb CVisc50 cohesive OVD compared to the Alcon ProVisc® cohesive OVD when used in cataract surgery.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must be at least 45 years old and have a clinically documented diagnosis of age-related non-complicated cataract that is considered amenable to treatment with standard phacoemulsification cataract extraction and IOL implantation.
- •The participant must have the capability to provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
- •The participant must be willing and able to undergo all pre-surgical and surgical procedures and to return for all scheduled follow-up examinations through 90 days following surgery.
- •The participant must have clear intraocular media other than the cataract in the operative eye.
排除标准
- •The participant has participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or plans to do so during the period of study participation.
- •The participant has any corneal pathology (for example; significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye.
- •The participant has anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (for example; pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the operative eye.
- •The participant has any condition which prevents reliable specular microscopy in the operative eye.
- •The participant has a congenital ocular anomaly (for example; aniridia, congenital cataract) in the operative eye.
- •The participant has a baseline ECD <1500 cells/square millimeter (mm^2) in the operative eye.
- •The participant has a grade 4+ nuclear cataract density in the planned operative eye.
- •The participant has glaucoma or ocular hypertension (IOP >24 mmHg) in the operative eye.
- •The participant has any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye.
- •The participant has a known allergy to any of the components of the test or control OVDs.
- •The participant is using any topical or systemic medications known to interfere with visual performance or complicate cataract surgery within 30 days of enrollment or during the study.
- •The participant is scheduled to undergo other combined intraocular procedures during the cataract/intraocular lens (IOL) implantation surgery in the operative eye. NOTE: A relaxing keratotomy is allowed.
- •The participant has diabetic retinopathy, wet age-related macular degeneration or other retinal pathology which might limit postoperative visual acuity (VA) or predispose the participant to postoperative retinal complications in the operative eye.
- •The participant's fellow eye is already participating in this study.
- •The participant has a history of chronic or recurrent inflammatory eye disease (for example; iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye.
- •The participant has a best corrected distance visual acuity (BCDVA) of logarithm of minimum angle resolution (LogMAR) 1.0 (20/200, 6/60) or worse in the fellow eye.
- •The participant has had previous corneal surgery in the planned operative eye.
- •The participant has a previous retinal detachment in the operative eye.
- •Females of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 12 months) are excluded from participation in the study if they are currently pregnant; plan to become pregnant during the study; and/or are breast-feeding.
结局指标
主要结局
Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days)
时间窗: Baseline, 90 Days ± 14 Days
Percentage of Participants Who Experienced at Least One Intraocular Pressure (IOP) Measurement ≥30 Millimeters of Mercury (mmHg) at Any Post-Surgical Follow-up Visit
时间窗: Up to 90 Days ± 14 Days
次要结局
- Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit(Baseline, 6-hour post-operative)
- Percentage of Participants With Summed Score for Anterior Chamber Cells and Flare Greater Than Zero at the 6-Hour and 24-Hour Post-Operative Visits(6-hour and 24-hour post-operative)
- Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit(Baseline, 24-hour post-operative)
研究者
研究点 (43)
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