MIGS VS SLT in Glaucoma Patients: Prospective Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- change in the intraocular pressure compared to baseline
研究概览
简要总结
To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat primary open angle glaucoma (POAG).
详细描述
Eligible study patients diagnosed with POAG and not sufficiently controlled by, intolerant of, or non-compliant with their current IOP-lowering regimen. Patients with IOP>21 mm Hg upon at least two consecutive measurements. Study subjects with typical glaucomatous visual field (VF) loss on Octopus or Humphrey automated perimetry (Carl Zeiss Meditec, Dublin, CA) and glaucomatous alterations to the optic nerve head. Visual field classified as glaucomatous according to the European Glaucoma Society guidelines.
Exclusion criteria : eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary open angle glaucoma diagnosis, intolerant or unresponsive to therapy or not controlled with therapy
排除标准
- •eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids
结局指标
主要结局
change in the intraocular pressure compared to baseline
时间窗: up to 12 months
measurement with GAT in mm Hg
次要结局
- change in the number of glaucoma medications compared to baseline(up to 12 months)
研究者
Antonio Fea
Aggregate Professor
University of Turin, Italy