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A Prospective, One-center Clinical Trial to Identify the Safety and Feasibility of Sutureless Pars-plana Vitrectomy Performed in Sub-tenon Anesthesia.
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.
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. Objectives: Primary outcome: The evaluation of 1. sensation of pain, 2. patients' intraoperative discomfort and 3. visual sensations using the standardized questionnaires (WONG-BAKER Faces Scale, Visual Analog Scale and individual questions). Secondary Outcome: The evaluation of 1. chemosis, 2. eye movement, 3. surgeon's general feeling of comfort during surgery (rating scale).
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Clinic for Ophthalmology, University Hospital RWTH Aachen
Aachen, Germany
Start Date
November 7, 2019
Primary Completion Date
December 31, 2021
Completion Date
March 31, 2022
Last Updated
May 5, 2022
67
ACTUAL participants
minimally invasive vitrectomy under subtenon anaesthesia
PROCEDURE
Lead Sponsor
RWTH Aachen University
Data Source & Attribution
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