An Open Two-center Study Evaluating the Safety of Hyaluronan Thiomer i.o. Implant During Combined Phacoemulsification - Non Penetrating Deep Sclerectomy in Patients With Open Angle Glaucoma and Cataract
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
The study is designed to assess the safety of Hyaluronan Thiomer i.o. implant in patients with primary open angle glaucoma undergoing a combined phacoemulsification - non penetrating deep sclerectomy procedure.
In this study, Hyaluronan Thiomer i.o. will be implanted during a combined surgery of cataract and non - penetrating deep sclerectomy in a group of 16 patients with primary open angle glaucoma and clinically significant cataract. Given that a considerable number of glaucoma patients also suffer from cataract, it is reasonable to test Hyaluronan Thiomer i.o. during a combined procedure of phacoemulsification and deep sclerectomy. This is also of importance because a combined procedure avoids the need of a second operation in this group of patients. Finally, it has been shown that combined phacoemulsification - deep sclerectomy does not induce a further risk compared to deep sclerectomy alone(open phase I study).
Safety will be assessed based on the occurrence of adverse events.
Efficacy assessments will be performed at every visit and efficacy analysis will include:
- Proportion of subjects at each study time point which will need additional IOP lowering drug therapy to achieve an IOP reduction to values < 21 mmHg. If a subject needs more than one drug to achieve target IOP, the number of drugs needed to achieve adequate IOP reduction will be recorded.
- Proportion of subjects at each time point which will need Neodymium:YAG goniopuncture to achieve an IOP reduction to values < 21 mmHg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged over 18 years
- •Primary open angle glaucoma with uncontrolled IOP (IOP > 21 mmHg or more) despite maximally tolerated topical medication
- •Clinically significant cataract as judged by the investigator
- •Scheduled for combined cataract/glaucoma surgery
排除标准
- •Any of the following will exclude a subject from the study:
- •Participation in a clinical trial in the 3 weeks preceding the study
- •Presence or history of a severe medical condition as judged by the clinical investigator
- •Wearing of contact lenses
- •Loss of mean deviation of visual field testing of 15 dB or more
- •Diabetic retinopathy
- •Dysgenetic glaucoma, secondary glaucoma or any type of angle closure glaucoma
- •Previous argon laser trabeculoplasty
- •Severe dry eye syndrome as judged by the investigator
- •Ocular infection or clinically significant inflammation as judged by the investigator
- •Ocular surgery in the 12 months preceding the study
- •History of glaucoma surgery in the study eye
- •Neovascular form of age related macular degeneration
- •The following lenses will not be implanted during cataract surgery Multifocal lenses Toric lenses PMMA lenses
- •Ametropy >/= 6 Dpt
- •Patients in which the surgical procedure cannot be performed or completed according to the protocol for any reason will be excluded and replaced.
- •Pregnancy, planned pregnancy or lactating
结局指标
主要结局
Safety
时间窗: Safety will be assessed up to 12 months.
Safety will be based on the occurrence of adverse events.
次要结局
- Efficacy(Efficacy assessments will be performed up to 12 months.)