An Ambispective, Monocentric, Non-interventional Long-term Follow-up Trial to Evaluate the Effectiveness and Safety of the Hydrus Implant Combined With Concomitant Phacoemulsification for Lowering Intraocular Pressure (IOP) in Glaucoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- • Mean non washed out IOP (mmHg) reduction after 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification
研究概览
简要总结
The purpose of this study is to evaluate the long-term effectiveness and safety of the Hydrus implant combined with concomitant phacoemulsification for lowering intraocular pressure (IOP).Glaucoma patients often have high intraocular pressures (IOP) and need long-term IOP control to prevent loss of visual function and blindness. To date, data on the results of up to 5 years after Hydrus implantation have been published. However, to our knowledge, long-term data over a longer period of time are not yet available. The implementation of this study with a follow-up of the patients after ≥ 8 years (up to 14 years) represents the longest follow-up period to date with a cohort of up to 202 eyes in Mainz, Germany. It enables the collection of "real world data" ≥ 8 years after the Hydrus implantation and provides information about the current status of glaucoma and the effect of the Hydrus implant over this long period (including IOP status, IOP-lowering interventions that have taken place in the meantime, the status of the IOP-lowering medications used, ocular safety, quality of life etc.).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patient participated in one of the following trials in the clinical trial site in Mainz:
- •the Ivantis, Inc. HYDRUS I trial (NCT03065036),
- •the Ivantis, Inc. HYDRUS II trial (NCT01818115),
- •the Ivantis, Inc. HYDRUS IV trial (NCT01539239),
- •or in the retrospective SPECTRUM data collection.
- •Patient received either concomitant implantation of the Hydrus implant and phacoemulsification or the Hydrus implant alone or participated in the control group (phacoemusification alone)
- •Patient has a minimum follow-up period after surgery of 8 years at the study visit
- •Willingness to participate in the study, the subject's signed and dated informed consent must be submitted before the start of the study
- •Ability of subject to give consent
排除标准
- •1. Simultaneous participation in another interventional study or past interventions whose effect may still be ongoing (30 days)
研究组 & 干预措施
smaller subgroups as the control group,whom underwent not a combined surgery
smaller subgroups will be analyzed that received Hydrus implantation alone or phacoemulsification alone (control group) or Hydrus implantation in both eyes.
The subjects whom underwent Hydrus implant combined with phacoemulsification
The subjects whom underwent Hydrus implant combined with concomitant phacoemulsification for lowering intraocular pressure (IOP), to evaluavte the long term effectiveness and safety.
结局指标
主要结局
• Mean non washed out IOP (mmHg) reduction after 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification
时间窗: 8 years
• Assess the mean IOP(mmHg) after 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification
次要结局
- Effect of IOP lowering medications in those Glaucoma patients whom underwent combined Hydrus stent implantation and Phacoemulsification.(8 years)
- Rate of Progression of Mean defect in visual field examination in Glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification(8 years)
- Numbers of IOP lowering secondary surgical interventions during 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification.(8 years)
- Differentiation of IOP reduction and safety between eyes of the patients after 8-years of follow-up (in subjects who received the Hydrus implant in both eyes)(8 years)
研究者
Katrin Lorenz
Prof. Dr. Dr
Johannes Gutenberg University Mainz