ISRCTN23263504已完成不适用
A pilot study to assess the safety and efficacy of the Transcend CyPass glaucoma implant in patients with open angle glaucoma who have failed medical treatment
Transcend Medical, Inc.™ (USA)0 个研究点目标入组 20 人开始时间: 2010年6月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males or females 18 years of age or older
- •2. Diagnosis in the study eye of primary open angle glaucoma (POAG) or open angle glaucoma associated with pseudoexfoliation syndrome or pigmentary glaucoma
- •3. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits
- •4. Intra-ocular pressure (IOP) of greater than or equal to 21 mmHg and less than or equal to 40 mmHg while on maximal tolerated medical therapy, documented at two sequential visits at any time of day, at least 48 hours apart, within 45 days prior to surgery
- •5. Patients must sign and witness the current Informed Consent Document
- •6. Patients must have sufficient space of the angle to accommodate the device
排除标准
- •1. Visual acuity of light perception or less in the study eye
- •2. Any previous surgery for any aqueous shunt device
- •3. Prior laser treatment of the retina
- •4. Any ophthalmic surgery performed within three months prior to study
- •5. Diagnosis of angle closure following penetrating keratoplasty, neovascular glaucoma, congenital glaucoma, developmental glaucoma, previous goniotomy, active uveitis within six months, or other secondary glaucomas (except pseudoexfoliation syndrome or pigmentary glaucoma, which are allowed)
- •6. Best corrected visual acuity (BCVA) less than 20/200 in the fellow eye
- •7. Active diabetic retinopathy
- •8. Clinically significant inflammation or infection within six months prior to study
- •9. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator
- •10. Participation in any study involving an investigational drug within the past 45 calendar days, or ongoing participation in a study with an investigational device
- •11. Intolerance or hypersensitivity to topical anesthetics, mydriatics, or components of the device
- •12. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
- •13. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient
- •14. Female patients of childbearing potential less than 1 year postmenopausal, and not surgically sterilised, who are not on a medically-acceptable form of birth control
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