A Prospective, One-center Clinical Trial to Identify the Safety and Feasibility of Sutureless Pars-plana Vitrectomy Performed in Sub-tenon Anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Discomfort
研究概览
简要总结
The aim of this prospective study is to investigate the feasibility of performing minimally invasive vitrectomy under sub-tenon anesthesia in terms of intraoperative patients' tolerance and the surgeon's confidence. In particular, the tolerance and pain sensation during the operation as well as the possible perception of light and colour sensations are to be recorded with the help of questionnaires. In addition, the surgeon's impressions regarding eye motility, chemosis and general feasibility will be evaluated.
详细描述
A prospective, one-center clinical trial to identify the safety and feasibility of sutureless pars-plana vitrectomy performed in sub-tenon anesthesia.
Background:
In Germany pars-plana vitrectomies are mostly performed in general anesthesia. This requires the immediate availability of a trained anesthesiology team, which is not always granted, especially in urgent eye disease (i.e. endophthalmitis, high risk retinal detachment). Furthermore, some patients are not suitable for general anesthesia due to systemic diseases (i.e. cardio-vascular diseases). There are several procedures of local ocular anesthesia (i.e. peribulbar, retrobulbar, sub-tenon anesthesia). The main advantage of sub-tenon anesthesia is the use of a blunt cannula limiting the risk of potential complications.
Purpose:
The purpose of this study is to investigate the safety of local sub-tenon anesthesia procedure for sutureless vitrectomy (anesthetic mixture: 2ml xylocaine and 2ml bupivacaine) in a prospective clinical study design.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 40 years
- •Presence of a clinical condition that requires surgical treatment with vitrectomy and does not necessarily require general anesthesia (retinal detachment, endophthalmitis, vitreous hemorrhage, after silicone oil surgery, vitreomacular traction, epiretinal gliosis, macular holes, subretinal bleeding, lens luxation).
- •The medical indication for vitrectomy is not linked to study participation. Not until the patient has consented to the vitrectomy (standardized information forms) potential study subjects will be approached to participate in the clinical trial.
- •Willingness to participate in the clinical trial
- •Understanding the objectives of the clinical trial and the study process
- •Signed informed consent form
排除标准
- •Concomitant diseases of the eye
- •State after filtering glaucoma operations
- •Distinct corneal opacities, which make the examination considerably more difficult
- •Complicated proliferative vitreoretinopathy
- •Lack of understanding of the study, its objectives and study conduct
- •Psychiatric diseases
- •Pregnancy
- •Simultaneous participation in another clinical trial
结局指标
主要结局
Discomfort
时间窗: 1 Day
11-point numeric scale ranges from '0' (means "no discomfort") to '10' (means "worst discomfort imaginable"), Questionnaire
Sensation of pain
时间窗: 1 Day
1. 11-point numeric scale ranges from '0' (means "no pain") to '10' (means "worst pain imaginable"), Questionnaire 2. Wong-Baker FACES® Scale (6 Faces, range no hurt - hurts worst), Questionnaire
Visual Sensations
时间窗: 1 Day
4 questions, Likert scale ("yes", "no", "don't know/not sure"), Questionnaire 1. perception of details during surgery (instruments, surgeon's face) 2. perception of colors during surgery 3. perception of lights or shadows 4. no light perception at all during surgery
次要结局
- Chemosis(1 Day)
- Eye movement(1 Day)
- Surgeon's general feeling of comfort during the surgery(1 Day)
研究者
Antonis Koutsonas
Dr. med. Antonis Koutsonas
RWTH Aachen University