Hydrus® 微支架新注册批准后研究 (CONFIRM)
Hydrus® 微支架新注册批准后研究：一项前瞻性、非随机化、多中心、单臂、临床试验
The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.
研究概览
详细说明
Qualified subjects will attend a screening visit, a surgical visit (Day 0), and 8 scheduled postoperative visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24.
This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Alcon Call Center
- 电话号码：1-888-451-3937
- 邮箱：alcon.medinfo@alcon.com
学习地点
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California
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Irvine、California、美国、92618
- 完全的
- Coastal Vision
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Sacramento、California、美国、95815
- 招聘中
- Sacramento Eye Consultants
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Colorado
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Loveland、Colorado、美国、80538
- 招聘中
- Eye Center of Northern Colorado
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Iowa
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Sioux City、Iowa、美国、51104
- 招聘中
- Jones Eye Center PC
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Kansas
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Overland Park、Kansas、美国、66213
- 尚未招聘
- Stiles Eyecare Excellence Cataracts and Glaucoma
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Maryland
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Rockville、Maryland、美国、20852
- 尚未招聘
- Visionary Eye Doctors
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Michigan
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Fraser、Michigan、美国、48026
- 招聘中
- Fraser Eye Care Center
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Minnesota
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Coon Rapids、Minnesota、美国、55433
- 招聘中
- Twin Cities Eye Consultants
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Missouri
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Chesterfield、Missouri、美国、63017
- 招聘中
- Midwest Vision Research Foundation
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Kansas City、Missouri、美国、64154
- 尚未招聘
- Moyes Eye Center
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Nevada
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Las Vegas、Nevada、美国、89145
- 招聘中
- Center for Sight
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North Carolina
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Southern Pines、North Carolina、美国、28387
- 招聘中
- Carolina Eye Associates PA
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Ohio
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Brecksville、Ohio、美国、44141
- 完全的
- Cleveland Eye Clinic
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Cincinnati、Ohio、美国、45242
- 招聘中
- Cincinnati Eye Institute
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Mason、Ohio、美国、45040
- 尚未招聘
- Cincinnati Eye / Apex Eye
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Pennsylvania
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Cranberry Township、Pennsylvania、美国、16066
- 尚未招聘
- Scott & Christie and Associates, PC
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Texas
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Austin、Texas、美国、78731
- 招聘中
- Texan Eye / Keystone Research
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Dallas、Texas、美国、75231
- 尚未招聘
- Glaucoma Associates Of Texas
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El Paso、Texas、美国、79902
- 招聘中
- El Paso Eye Surgeons
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Hurst、Texas、美国、76054
- 招聘中
- Texas Eye Research Center
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Utah
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Salt Lake City、Utah、美国、84107
- 尚未招聘
- The Eye Institute of Utah
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Wisconsin
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Kenosha、Wisconsin、美国、53142
- 招聘中
- Eye Centers Of Racine And Kenosha
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse;
- Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications;
- Optic nerve appearance characteristic of glaucoma;
- Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Closed angle forms of glaucoma;
- Congenital or developmental glaucoma;
- Secondary glaucoma;
- Use of more than 4 ocular hypotensive medications;
- Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery;
- Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal;
- Other protocol-defined exclusion criteria may apply.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Hydrus Microstent
Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL) |
Crescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal immediately following placement of a monofocal IOL. Cataract surgery performed using standard anesthesia and phacoemulsification techniques Commercially available monofocal intraocular lens as determined by the investigator |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of occurrence of clinically significant device malposition associated with clinical sequelae
大体时间：Day 0 operative, up to Month 24 postoperative
|
The position of the implant will be assessed visually intraoperatively and at each postoperative follow-up visit. Examples of clinically significant device malposition associated with clinical sequelae as listed in the protocol include secondary surgical intervention to modify device position or to remove the device (explantation), corneal endothelial touch by device, iris touch by the device associated with intraocular inflammation, pigment dispersion or other sequelae, central endothelial cell loss ≥30 percent, compromised corneal function, best-corrected visual acuity (BCVA) loss of 2 lines (10 letters) or more on the ETDRS chart, device obstruction requiring secondary surgical intervention, persistent anterior chamber inflammation with peripheral anterior synechiae, persistent anterior chamber inflammation without peripheral anterior synechiae, and chronic pain. |
Day 0 operative, up to Month 24 postoperative
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of occurrence of intraoperative ocular adverse events
大体时间：Day 0 operative
|
Intraoperative ocular adverse events as specified in the protocol include hyphema obscuring the surgeon's view, choroidal hemorrhage or effusion, choroidal detachment, significant iris injury or trauma, corneal abrasion, corneal edema, zonular dialysis, cyclodialysis, cyclodialysis cleft, iridodialysis, vitreous loss not associated with the cataract procedure, inadvertent perforation of the sclera, and Descemet's membrane detachment. |
Day 0 operative
|
|
Rate of occurrence of sight threatening postoperative adverse events
大体时间：Up to Month 24
|
Sight threatening, post-operative adverse events as specified in the protocol include endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, and aqueous misdirection. |
Up to Month 24
|
|
Rate of occurrence of other postoperative ocular adverse events
大体时间：Up to Month 24
|
Other postoperative ocular adverse events as specified in the protocol include anterior uveitis/iritis, non-persistent & persistent, best corrected visual acuity (BCVA) loss of 2 lines or more, chronic pain, device migration, device obstruction, peripheral anterior synechiae (PAS), ocular secondary surgical interventions for intraocular pressure (IOP) or glaucoma management, hypotony at or after 1 month postop, hyphema, corneal opacification, corneal edema persisting or severe corneal edema, other retinal complications, elevated mean IOP >/=10 millimeters mercury (mmHg) vs screening, iris prolapse/wound incarceration, significant foreign body sensation at or after 3 months postop, surgical re-intervention, and worsening of visual field. |
Up to Month 24
|
合作者和调查者
调查人员
- 研究主任：Clinical Project Lead, CDMA Surgical、Alcon Research
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.