Topical Anesthesia vs. Analgosedation and Pain in Micropulse Transscleral Glaucoma Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Pain at 1 day postop
研究概览
简要总结
Topical Anesthesia will be compared to Analgosedation for pain control in Micropulse Transscleral Laser Treatment for Glaucoma (MP-TLT).
详细描述
For a patient, the perspective of a surgical treatment can mean both, hope, and anxiety. In particular the fear of pain during and after surgery can cause tremendous anxiety. In addition, possible side effects of general anesthesia and sedation should be considered, in particular, in patients with multiple comorbidities. The investigators want to help patients to cope with their anxiety and, in addition, minimize risks of surgical procedures including side effects of anesthesia. With this project, the investigators aim to investigate whether topical anesthesia - often used in ophthalmologic surgical procedures - can sufficiently control pain during and after a glaucoma laser procedure compared to intravenous analgosedation. As primary objective, the effectiveness in pain control of analgosedation and topical anesthesia in MP-TLT will be compared. As secondary objective, the effect of the anesthetic protocol used on postoperative visual related quality of life will be investigated.
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
盲法说明
non
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
- •diagnosis of primary open angle glaucoma (POAG)
- •age ≥18 years of age
- •Visual acuity ≥0.6 Decimal-Snellen
- •IOP ≥21 mmHg
- •</=3 anti-glaucoma drug (AGD) classes
排除标准
- •Diagnosis of cystoid macula edema (CME) observed by optical coherence tomography (OCT)
- •Status post CME
- •Diagnosis of epiretinal fibroplasia
- •Status post other operations than uncomplicated cataract interventions
- •Status post cataract operation less than 3 months ago
结局指标
主要结局
Pain at 1 day postop
时间窗: 1 day postop
Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)
Pain at 1 hour postop
时间窗: 1 hour postop
Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)
Pain at 6 hours postop
时间窗: 6 hours postop
Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)
次要结局
- Change in number of hypotensive medication(at 1 month)
- Pain at 1 week postop(1 week postop)
- Pain at 1 month postop(1 month postop)
- Change in Goldman-applanation intraocular pressure(at 1 month)
- Change in best corrected decimal Snellen visual acuity(at 1 month)
- visual related quality of life(at 1 month)