5 Years Long Term Results After Standalone CyPass-Implantation
2022年3月17日 更新者：Dietrich-Bonhoeffer-Klinikum
Retro- and Prospective Monocentric Study to Evaluate the Safety and Effectiveness of the CyPass Stent 5 Years After Implantation
This study evaluates the results of all clinically relevant findings of glaucoma diagnostics 5 Years after stent-implantation concerning the safety and effectiveness of the cypass stent procedure.
The comparison of Preoperative and long term postoperative results is the aim of this study to evaluate this young procedure of Glaucoma surgery
研究概览
详细说明
This is a post market study without interventions.The participants have been treated with CyPass-Stent implantation between 3 and 7 years ago to control the intraocular pressure .
They will be invited for only one follow up visit to determine the present glaucoma status again, to determine the long term safety and effectiveness of the cypass stent procedure and to see whether addition therapy or surgical intervention is necessary.
研究类型
观察性的
注册 (实际的)
230
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Mecklenburg/Vorpommern
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Neubrandenburg、Mecklenburg/Vorpommern、德国、17036
- Dietrich-Bonhoeffer-Klinikum
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
130 Patient with at least one treated eye
描述
Inclusion Criteria:
- patients who have undergone a standalone cypass implantation at least 3 years ago
- signed inform consent
Exclusion Criteria:
- Patients with too much travel distance between study center and home
- Patients who cannot visit the studycenter due to health problems
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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standalone CyPass implantation
patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
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Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination
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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 |
|---|---|---|
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Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg
大体时间：up to 7 years
|
The Measurement of the intraocular Pressure is a criterion for the Efficacy of CyPass Stent Procedure (success rate).
The postoperative target pressure of 15 mmHg, 18 mmHg or 21 mmHg (depends on Glaucoma Status) has to be achieved.
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up to 7 years
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Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination)
大体时间：up to 7 years
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The Measurement of the intraocular Pressure change is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative pressure after 5 to 7 years has to be compared with the preoperative intraocular pressure (in mmHg) The change was calculated only from two time points. (value at the final examination time point minus the value at the preoperative time point |
up to 7 years
|
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Number of Additional Medication
大体时间：up to 7 years
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The number of additional Glaucoma medication is another criterion to determine the Efficacy of CyPass Stent Procedure (success rate). Up to 4 different active substance can be used to reduce the pressure. The more substances the patient uses postoperatively the lower is the success after implantation of the CyPass-Stent. The postoperative number of medications after 5 years has to be compared with the preoperative number |
up to 7 years
|
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Number of Participants With Secondary Glaucoma Procedures
大体时间：up to 7 years
|
To determine the efficacy of CyPass Stent procedure completely the number of secondary glaucoma interventions (surgery/ laser) has to be documented
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up to 7 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Stability of Optic Nerve
大体时间：up to 7 years
|
The Measurement of the optic nerve (HRT) in comparison to the baseline is needed to evaluate the glaucoma damage and to determine the Longterm success rate and the safety of the CyPass- Stent-Procedure. With papillary tomography you can see the changes in the optic nerve head concerning the permanent failures of retinal vessels , measure them very precisely and compare them with the previous findings. |
up to 7 years
|
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Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness
大体时间：up to 7 years
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The comparison of the preoperative and postoperative Status of the Retinal Nerve Fiber Layer Thickness and retinal fundus thickness is another criterion to determine the absolute and relative success.
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up to 7 years
|
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Number of Participants With Stability of Visual Field
大体时间：up to 7 years
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The parameter of the Visual Field (Mean Deviation) will be measured to evaluate the Safety of the CyPass-Procedure.
The visual Field shows the progression of glaucoma defects concerning failures in different parts for example in the center or in the periphery of the visual field.
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up to 7 years
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Number of Participants With Stability of Stent Position
大体时间：up to 7 years
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Determination of Stent Position in the angle will be performed to exclude moving of the Stent.
The stent could change it's position forward into the anterior chamber or backwards in the suprachorioidal space
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up to 7 years
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Number of Participants With Stability of Stent Tissue Interaction
大体时间：up to 7 years
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Determination of iris tissue reaction to the stent will be performed.
We document slight reaction without involving the opening, iris reaction with involving the opening and complete closure by tissue.
The iris Tissue could overgrow the opening of the stent and therfore the function of the stent is disturbed or even failed.
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up to 7 years
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Number of Participants With Intra-and Postoperative Complications
大体时间：up to 7 years
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The number of intra-and postoperative complications are needed to evaluate the safety of the CyPass-procedure
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up to 7 years
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Number of Participants With Suprachoroidal Bleb
大体时间：up to 7 years
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The Determination of the suprachoroidal bleb is needed to evaluate the function of the stent and the efficacy of the procedure.
The bigger the bleb, the lower the pressure and the better the efficacy of the stent
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up to 7 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Helmut Hoeh, MD,FEBO、Department of Ophthalmology, Neubrandenburg, Germany
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Garcia-Feijoo J, Rau M, Grisanti S, Grisanti S, Hoh H, Erb C, Guguchkova P, Ahmed I, Grabner G, Reitsamer H, Shaarawy T, Ianchulev T. Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing Topical Therapy: 1-Year Results of a Multicenter Study. Am J Ophthalmol. 2015 Jun;159(6):1075-1081.e1. doi: 10.1016/j.ajo.2015.02.018. Epub 2015 Mar 3.
- Hoeh H, Vold SD, Ahmed IK, Anton A, Rau M, Singh K, Chang DF, Shingleton BJ, Ianchulev T. Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent. J Glaucoma. 2016 Jan;25(1):106-12. doi: 10.1097/IJG.0000000000000134.
- Grisanti S, Margolina E, Hoeh H, Rau M, Erb C, Kersten-Gomez I, Dick HB, Grisanti S. [Supraciliary microstent for open-angle glaucoma: clinical results of a prospective multicenter study]. Ophthalmologe. 2014 Jun;111(6):548-52. doi: 10.1007/s00347-013-2927-6. German.
- Hoh H, Grisanti S, Grisanti S, Rau M, Ianchulev S. Two-year clinical experience with the CyPass micro-stent: safety and surgical outcomes of a novel supraciliary micro-stent. Klin Monbl Augenheilkd. 2014 Apr;231(4):377-81. doi: 10.1055/s-0034-1368214. Epub 2014 Apr 25.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年2月1日
初级完成 (实际的)
2018年2月28日
研究完成 (实际的)
2020年4月1日
研究注册日期
首次提交
2017年4月4日
首先提交符合 QC 标准的
2017年4月10日
首次发布 (实际的)
2017年4月14日
研究记录更新
最后更新发布 (实际的)
2022年7月14日
上次提交的符合 QC 标准的更新
2022年3月17日
最后验证
2018年8月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
results will be published in ophthalmological journals
IPD 共享时间框架
results are planned to published in December 2020
IPD 共享访问标准
Publication in ophthalmological journals provided and checked by Ahmed Medra
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
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