NL-OMON39988已完成3 期
THE HYDRUS II TRIAL: A PROSPECTIVE, MULTICENTER, RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE HYDRUS IMPLANT FOR LOWERING INTRAOCULAR PRESSURE IN GLAUCOMA PATIENTS UNDERGOING CATARACT SURGERY - CP-10-001 (Ivantis, Hydrus, Implant)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 17
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Male and female patients, from 21 to 80 years of age.
- •A diagnosis of primary open angle glaucoma (POAG) or pseudoexfoliative glaucoma.
- •At the Screening Visit, a mean (or median) IOP of <24 mmHg on 4 or fewer glaucoma medications.
- •At the Baseline Visit, a mean unmedicated diurnal IOP of >= 21 mmHg and <= 36 mmHg. Alternately, an average of the unmedicated Baseline (non-diurnal) IOP and the Operative Day IOP >= 21 mmHg and <= 36 mmHg.
- •An operable age-related cataract with visual impairment or glare, eligible for phacoemulsification.
- •Diagnosis of glaucoma substantiated by ophthalmoscopy and an automated visual field test using a Humphrey automated visual field analyzer within 90 days prior to the Screening Visit. Mean deviation score must be <0.
- •If visual field testing is not confirmatory, but the subject has utilized ocular hypotensive medications for >= 3 months prior to enrollment, optical scanning lasers and optic disc
- •photography confirming disc morphology may be used to establish the diagnosis of glaucoma. Acceptable optical scanning laser diagnostics include:
- •1. Heidelberg Retina Tomography (HRT) abnormal nerve fiber layer (NFL) findings indicated by a yellow exclamation mark and/or a red x.
- •2. Zeiss/Humphrey Glaucoma Diagnostic unit - GDx abnormal NFL findings with a Nerve Fiber Index (NFI) reading of > 31 and/or < 5% p-value indicator for NFL.
- •3. Optical Coherence Testing (OCT) abnormal NFL findings in the red or yellow areas, below the area of normal on the Analysis of Thickness.
- •Gonioscopy confirming normal angle anatomy at site of implantation.
- •Anterior chamber angle Shaffer grade of >= III.
- •Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits.
排除标准
- •Closed angle forms of glaucoma.
- •Secondary glaucoma (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venuous pressure; congenital or developmental glaucoma.
- •Significant risk due to washout of medication.
- •Previous argon laser trabeculoplasty (ALT), cyclodestructive procedure, trabeculectomy, tube shunts, or any incisional glaucoma surgical procedure.
- •Inability to complete a reliable 24-2 SITA Standard Humphrey visual field on the study eye at screening (fixation losses, false positive errors and false negative errors shoud not be greater than 33%).
- •Use of more than 4 ocular hypotensive medications. (Note: Combination medications count as 2 medications.)
- •Central corneal thickness > 620 or < 480 microns.
- •Best corrected visual acuity worse than 20/80 in the fellow eye.
- •Proliferative diabetic retinopathy.
- •Previous surgery for retinal detachment.
- •Clinically significant corneal dystrophy.
- •Previous corneal surgery.
- •Previous refractive surgery, including previous phakic IOL surgery.
- •Previous or planned iridectomy surgery on the study eye.
- •Degenerative visual disorders such as wet age-related macular degeneration or non-retinal laser surgery.
- •Clinically significant ocular pathology, other than cataract and glaucoma.
- •Clinically significant ocular inflammation or infection within thirty days prior to screening.
- •Uncontrolled systemic disease that in the opinion of the Investigator would put the subject*s health at risk and/or prevent the subject from completing all study visits.
- •Concurrent participation in another clinical study , or completion in another study within the past 30 days.
- •Pregnant, nursing females, or women who are of childbearing potential who are not using an acceptable method of contraception.
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