Differences in Nycthemeral IOP Variation and Outflow Facility After Filtering Microshunt Versus Canal-Based Ab Interno Glaucoma Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Intraocular pressure variation
研究概览
简要总结
The purpose of this study was to asses differences in nycthemeral (24-h) intraocular pressure (IOP) profiles and outflow facilities between patients who have undergone epibulbar microshunt implantation and ab interno trabeculectomy, respectively.
详细描述
Recent studies involving continuous, 24-hour intraocular pressure (IOP) monitoring in glaucoma patients linked IOP variation to disease progression.
No study has previously compared the postoperative IOP variation of microshunt (Preserflo, P) implantation to ab interno trabeculectomy (Trabectome, T).
In this prospective cohort, the investigators analyzed 68 patients (34 P and 34 T) who presented for 24-hour IOP monitoring 6 to 12 months after surgery. Surgery must have been conducted between October 2020 and July 2021. Patients were assigned to each study group according to the intervention undergone, P or T. IOP and tonographic outflow facility were measured in the habitual position using a pneumatonometer. The IOP variation was considered the primary outcome measure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that have undergone microshunt implantation or ab interno trabeculectomy between 6-12 months ago
- •patients suffering from open-angle glaucoma
排除标准
- •Patients that have undergone microshunt implantation or ab interno trabeculectomy less than 6 months or over 12 months ago
- •patients suffering from angle-closure glaucoma
结局指标
主要结局
Intraocular pressure variation
时间窗: Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).
24-hour variation in intraocular pressure obtained by the use of a pneumatonometer.
次要结局
- Outflow facility(Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).)
- Intraocular pressure(Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).)