Assessment of Efficacy and Safety of the EX-PRESS® Glaucoma Filtration Device in Patients With Normal Tension Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS® Glaucoma Filtration Device (Ex-PRESS) in Japanese subjects with normal tension glaucoma.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of normal tension glaucoma.
- •Indicated for filtration surgery using Ex-PRESS®.
- •Understand and provide Informed Consent.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Women who are pregnant, lactating, or planning to be pregnant during the study period.
- •Diagnosis of angle closure glaucoma or secondary glaucoma.
- •History of glaucoma surgery.
- •Ophthalmologic surgery within the past 6 months.
- •Difficulty with applanation tonometry measurement.
- •Corneal dystrophy.
- •Infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye.
- •Severe blepharitis or dry eye.
- •History of metal allergy.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Ex-PRESS
Ex-PRESS® Glaucoma Filtration Device, Model P50PL, implanted in the anterior chamber of the study eye during glaucoma surgery intended for the lifetime of the patient
干预措施: Ex-PRESS® Glaucoma Filtration Device, Model P50PL (Device)
结局指标
主要结局
Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12
时间窗: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Percent Change From Baseline in IOP
时间窗: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.
Change From Baseline in IOP
时间窗: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.
Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP
时间窗: Month 3, Month 6, Month 12 Post-Operative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Secondary surgical treatment included needling, laser suture lysis, and conjunctival and scleral flap sutures. For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol. An eye may have received more than one procedure.
Mean Intraocular Pressure (IOP)
时间窗: Month 3, Month 6, Month 12 Post-Operative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP
时间窗: Month 3, Month 6, Month 12 Post-Operative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol.
次要结局
未报告次要终点