NCT05583591终止不适用
Prospective, Randomized Controlled Study Comparing Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma (COMPETE)
Diablo Eye Associates2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Percentage of subjects with complete success defined as intraocular pressure reduction > 25% from baseline And without secondary intervention to reduce IOP (medication, laser trabeculoplasty, or surgery) at 24 month.
研究概览
简要总结
The goal of the study is to prospectively evaluate and compare Hydrus microstent to the iStent Inject Wide in combination with cataract surgery in patients with mild to moderate open angle glaucoma. Hydrus and iStent are the two FDA approved trabecular meshwork targeting microstents to treat open angle glaucoma in conjunction with cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>60 years or older
- •Visually significant cataract
- •Mild to moderate primary open angle glaucoma controlled on medications
- •undergoing cataract surgery with lens implantation and concurrent microstent placement
- •IOP ≥ 21 mmHg and ≤ 36 mmHg after washout of ocular hypotensive medication(s)
- •CCT 480 to 620μm
- •No prior ocular surgery including corneal refractive surgery
- •No SLT within 6 months of baseline visit, no history of intracameral glaucoma drug eluting implants
- •Visual field mean deviation ≤ -12 dB
- •Optic nerve abnormalities consistent with glaucoma, C/D ratio less than ≤0.8
排除标准
- •Prior intraocular surgery
- •Visual field MD ≥ -12 dB
- •secondary glaucoma including uveitis, traumatic, malignant, neovascular, and congenital glaucoma.
- •Glaucoma related to elevated episcleral venous pressure including Sturge-Weber syndrome, thyroid eye disease, orbital tumor, and etc.
- •Uncontrolled intraocular pressure on maximum tolerated medical therapy;
- •Unable to perform wash-out IOP
- •Anatomic exclusion of narrow anterior chamber angle (Shaffer grade I-II), other angle abnormalities including angle closure glaucoma
- •Corneal disease or dystrophy
- •Pathological myopia with degeneration that affects diagnostic imaging
- •Clinically significant ocular pathology or degenerative diseases that affect vision, visual field, or optical coherence tomography of optic nerve.
- •Inability to perform reliable Visual Field and optical coherence tomography.
结局指标
主要结局
Percentage of subjects with complete success defined as intraocular pressure reduction > 25% from baseline And without secondary intervention to reduce IOP (medication, laser trabeculoplasty, or surgery) at 24 month.
时间窗: 24 Months
次要结局
- Intraoperative and postoperative adverse events rates(24 Months)
- Rates of needing incisional glaucoma surgery as secondary intervention to control interocular pressure(24 Months)
- Rates of secondary intervention to reduce intraocular pressure(24 Months)
研究者
研究点 (2)
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