Phase 4 Study to Evaluate Efficacy And Safety of Pneumatic Trabeculoplasty (PNT) in Subjects Affected by Primary Open Angle Glaucoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- intraocular pressure (IOP)
研究概览
简要总结
The purpose of this study is to evaluate prospectively the PNT safety and efficacy in term of IOP reduction in a group of previously or newly diagnosed glaucomatous subjects.
详细描述
A group of subjects affected by Primary Open Angle Glaucoma (POAG) underwent 3 PNT treatments to evaluate one-year efficacy in term of IOP reduction and one-year safety in term of incidence of adverse events
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
- Single (Care Provider)
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
- •Subjects affected by primary open angle glaucoma
排除标准
- •Any local or systemic contraindication to timolol topical therapy
- •Chronic iritis and/or uveitis in one or both eyes,
- •History of inflammatory glaucoma,
- •Hemorrhagic glaucoma,
- •Post-traumatic glaucoma,
- •Phacolytic glaucoma,
- •Acute glaucomatocyclitic attack,
- •Closed angle/narrow angle glaucoma in one or both eyes,
- •Previous corneal transplantation,
- •Proliferative diabetic retinopathy with/without iris neovascularisation,
- •Significative disk cupping (90% of complete disk area),
- •Large and severe perimetric defects (I. e. a central perimetric residual not above 10 central degrees),
- •Dry/wet age related macular degeneration in one or both eyes,
- •Previous glaucoma surgery (Laser therapy was not considered)
- •Keratitis
- •Severe dry eye disease,
- •Corneal dystrophies
- •High myopia (more than 6 dioptres)
- •Peripheral retinal degenerations with risk of retinal detachment
结局指标
主要结局
intraocular pressure (IOP)
时间窗: Patients will be followed for one year. Time-points:recruitment, Basal (30 days after recruitment), Follow-Up2 (30 days after basal), Follow-Up3 (3 months after basal), Follow-Up4 (6 months after basal), Follow-Up5 (one year after basal)
to evaluate one-year intraocular pressure (IOP) reduction after a standard pneumatic trabeculoplasty (PNT) treatment
次要结局
未报告次要终点
研究者
Luigi Varano, MD
M. D.
University of Catanzaro