NL-OMON40947已完成不适用
THE SAFETY AND EFFECTIVENESS OF THE HYDRUS AQUEOUS IMPLANT FOR LOWERING INTRAOCULAR PRESSURE IN GLAUCOMA PATIENTS UNDERGOING CATARACT SURGERY, A PROSPECTIVE,MULTICENTER, RANDOMIZED, CONTROLLED CLINICAL TRIAL - Hydrus 4 study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •INCLUSION CRITERIA:
- •Subjects must meet the following inclusion criteria to be eligible for the study eye
- •* Male and female patients, at least 45 years of age
- •* An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification; if BCVA is better than 20/40, testing with a BAT meter on a medium setting must result in BCVA 20/40 or worse
- •* A diagnosis of POAG treated with 1 to 4 hypotensive medications
- •* Optic nerve appearance characteristic of glaucoma
- •* Medicated IOP <= 31 mmHg
- •* Diurnal IOP >= 22 mmHg and <= 34 mmHg after wash out of ocular hypotensive medications
- •* IOP increase >= 3 mmHg after wash out of ocular hypotensive medications
- •* Visual field examination using Humphrey 24-2 SITA standard, meeting protocol specified minimum criteria for glaucoma defined as:
- •- Mild: visual field loss on Humphrey visual field testing, with mean deviation (MD) between 0 and -6dB; fewer than 25% of points depressed below the 5% level and fewer than 15% of points depressed below the 1% level on pattern deviation plot; and no point within central 5° with sensitivity <15dB
- •- Moderate: visual field loss on Humphrey visual field testing, with mean deviation worse than -6dB but no worse than -12dB; fewer than 50% of points depressed below the 5% level, and fewer than 25% of points depressed below the 1% level on pattern deviation plot; no points within central 5° with sensitivity of <=0dB; and only one hemifield containing a point with sensitivity <15dB within
- •5° of fixation
- •* In subjects where the VF exam is not confirmatory for glaucomatous defect, retinal nerve fiber layer optical scanning laser imaging supporting ophthalmoscopy findings shall be performed
- •* Shaffer grade >= III in all four quadrants
- •* Cup:disc (c:d) ratio <= 0.8
- •* Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair placement of the implant
- •* Subject is able and willing to attend scheduled follow-up exams for 2 years postoperatively (and up to 5 years postoperatively as part of a post-approval study)
- •* Subject understands and signs the informed consent;INTRAOPERATIVE ELIGIBILITY CRITERIA
- •Individuals who meet the following intraoperative eligibility criteria in the study eye will be randomized into the treatment or control arms of this study.;Subjects must have:
- •* An intact and centered capsulorrhexis
- •* An intact posterior capsular bag
- •* A well-centered monofocal IOL placed in the capsular bag
- •* A clear view of an open angle and visualization of the angle with direct gonioscopy
- •following intracameral instillation of a miotic agent, and;Subjects must not have:
- •* Evidence of zonular dehiscence/rupture
- •* Intraoperative floppy iris syndrome
排除标准
- •EXCLUSION CRITERIA
- •Excluded from the study will be individuals with the following characteristics. Unless specified otherwise, all ocular criteria refer to the study eye only.
- •* Closed angle forms of glaucoma
- •* Congenital or developmental glaucoma
- •* Secondary glaucoma (such as neovascular, uveitic, pseudoexfoliative, pigmentary, lensinduced,
- •steroid-induced, trauma induced, or glaucoma associated with increased episcleral venous pressure)
- •* Use of more than 4 ocular hypotensive medications (combination medications count as two medications)
- •* Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery
- •* Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm*s Canal
- •* 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 should not be greater than 33%)
- •* Use of oral hypotensive medication for glaucoma for treatment of the fellow eye
- •* Subjects with advanced glaucoma or any subject who presents with an unacceptable risk to the subject of a washout of ocular hypotensive medications
- •* Best corrected visual acuity worse than 20/80 in the fellow eye
- •* A 24-2 SITA Standard Humphrey visual field mean deviation (MD) of worse than -12dB in the fellow eye
- •* Central corneal thickness > 620 microns and < 480 microns
- •* Proliferative diabetic retinopathy
- •* Previous surgery for retinal detachment
- •* Previous corneal surgery or clinically significant corneal dystrophy, e.g., Fuch*s dystrophy (>12 confluent guttae)
- •* Unclear ocular media preventing visualization of the fundus or anterior chamber angle
- •* Degenerative visual disorders such as wet age-related macular degeneration
- •* Clinically significant ocular pathology, other than cataract and glaucoma
- •* Clinically significant ocular inflammation or infection within 6 months prior to screening
- •* Presence of extensive iris processes that obscure visualization of the trabecular meshwork
- •* Unable to discontinue use of blood thinners in accordance with surgeon*s standard postoperative instructions
- •* Known or suspected elevated episcleral venous pressure due to Sturge Weber, nanophthalmos, orbital congestive disease
- •* 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
- •* Current participation or participation in another investigational drug or device clinical trial (which includes the fellow eye) within the past 30 calendar days
- •* Pregnant or nursing women; or women of child bearing age not using medically acceptable contraceptives
研究者
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