NCT07698353进行中（未招募）不适用
A Clinical Feasibility Study of the Aquea Intracanalicular Glaucoma Micro-coil Stent
Aquea Health, Inc.1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2024年4月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
The purpose of this research study is to evaluate the safety and effectiveness of the Aquea Intracanalicular Glaucoma Stent in lowering intraocular pressure (IOP) in patients with cataract and open angle glaucoma.
The main questions it aims to answer are:
- What proportion of eyes will have a ≥ 20% decrease in IOP from the hypotensive medication-free baseline examination to the hypotensive medication-free 12-month postoperative examination.
- What is the mean change in IOP between the hypotensive medication-free baseline examination and hypotensive medication-free 12-month postoperative examination.
Participants will be screened for eligibility.
- Eligible subjects will be examined preoperatively to obtain a medical history and to establish a baseline for their ocular condition.
- Subjects will undergo implantation of the Aquea Intracanalicular Glaucoma Stent in one eye in conjunction with cataract surgery.
- Postoperatively, subjects will undergo evaluation at regularly scheduled intervals.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Ocular criteria apply to study eye only):
- •Subject Inclusion Criteria
- •Individuals 45 years of age or older, of either gender or any race, at the time of surgery.
- •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.
- •A diagnosis of cataract eligible for phacoemulsification cataract extraction and IOL implantation.
- •A diagnosis of primary open angle glaucoma (POAG) substantiated using funduscopic exam and at least one reliable visual field test (i.e., Mean Deviation [MD] < 0 with fixation losses ≤ 30%, false positive errors ≤ 30% and false negative errors ≤ 30%) with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm.
- •At the Screening Visit, medicated IOP of ≤ 25 mmHg or unmedicated IOP of ≥ 21 mmHg and ≤ 33 mmHg.
- •At the Baseline Visit, a mean unmedicated IOP of ≥ 21 mmHg and ≤ 33 mmHg. The mean will be derived from the diurnal IOP readings taken over the course of the Baseline Visit day. Additionally, the baseline mean unmedicated diurnal IOP must be ≥ 3 mmHg higher than the medicated IOP measured at the Screening Visit.
- •No changes in preoperative ocular hypotensive medication regimen for at least three months prior to Screening Visit.
- •Gonioscopy confirming normal angle anatomy at site of implantation.
- •Shaffer grade ≥ III in all four quadrants.
- •Subject Intraoperative Inclusion Criteria Individuals must meet the following intraoperative inclusion criteria to be eligible for this study. Ocular criteria relate to the study eye only.
- •Uncomplicated cataract extraction
- •A well-centered posterior chamber IOL implanted in the capsular bag.
- •A clear view of an open angle and visualization of the angle with direct gonioscopy post intracameral miotic instillation.
排除标准
- •Excluded from the study will be individuals with the following characteristics. Unless specified otherwise, all ocular criteria refer to the study eye only.
- •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 30%).
- •Use of more than 3 ocular hypotensive medications. (Combination medications count as 2 or 3 medications depending on number of active ingredients.)
- •Use of oral hypotensive medication treatment for glaucoma in the fellow eye.
- •Significant risk by a washout of medication including those subjects with advanced glaucoma evidenced by an afferent pupillary defect, a C:D ratio ≥ 0.9 or encroachment of field loss within the central 5 degrees as indicated by ≥ 2 depressed points of 0.5% probability on the 24-2 SITA Standard Humphrey visual field.
- •Previous glaucoma procedure with or without an implantable glaucoma device (with exception of laser treatments to the trabecular meshwork such as a Laser Trabeculoplasty performed more than three months prior to study enrollment).
- •Proliferative or severe nonproliferative diabetic retinopathy.
- •Previous surgery for retinal detachment.
- •Central corneal thickness > 620 microns.
- •Clinically significant corneal dystrophy.
- •Previous corneal surgery, except for pterygium excision and corneal relaxing incisions.
- •Wet age-related macular degeneration.
- •Clinically significant ocular pathology, other than glaucoma.
- •Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, elevated episcleral venous pressure, pigmentary or neovascular glaucoma.
- •Best corrected visual acuity worse than 20/80 in the fellow eye not attributable to cataract.
- •Clinically significant ocular inflammation or infection in the study eye 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.
- •Participation in any clinical trial within the 30 calendar days prior to Screening.
- •Pregnant or nursing females.
研究组 & 干预措施
Unmasked Single Arm
Other
Unmasked Single Arm
干预措施: Aquea Zealix™ (Device)
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 12 Months
Proportion of eyes with ≥ 20% decrease in IOP from the hypotensive medication-free baseline examination to the hypotensive medication-free 12-month postoperative examination.
次要结局
- Secondary Effectiveness Endpoint(12 Months)
研究者
研究点 (1)
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