NCT00597181终止4 期
A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open-Angle Glaucoma
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Aqueous humor flare
研究概览
简要总结
The less invasive nature of the Ex-Press Mini shunt with mitomycin C induces less post-operative inflammation than trabeculectomy with mitomycin c.
详细描述
The purpose of this study is to quantify the degree of post-operative inflammation in eyes which have undergone either trabeculectomy filtering surgery or Ex-Press mini shunt insertion. Early intraocular pressure control and postoperative complications will also be noted.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must:
- •Be willing and able to provide written Informed Consent.
- •Be able and willing to follow instructions on the use of post- operative medication and likely to complete the entire course of the study.
- •Be male or female of any race at least 18 years of age.
- •Have medically uncontrolled glaucoma for which they have elected to undergo surgery.
- •Diagnosed with primary open angle glaucoma, pigmentary or pseudoexfoliation glaucoma.
排除标准
- •No subject may:
- •Have any contraindication to intraocular surgery.
- •Diagnosed with: primary angle closure glaucoma, normal tension glaucoma, secondary glaucoma, neovascular glaucoma.
- •Have any active ocular disease other than glaucoma that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator.
- •Have laser ALT or SLT within the past 3 months or cataract surgery within the last six months.
- •Require use of ocular NSAID or systemic steroids.
- •Have known allergy or sensitivity to mitomycin C
- •Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement.
- •Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
- •Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation).
- •Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study.
结局指标
主要结局
Aqueous humor flare
时间窗: 2 months
次要结局
- Aqueous humor cell(2 months)
研究者
研究点 (2)
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