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).
Study Type
OBSERVATIONAL
Enrollment
67
The safety and feasibility in terms of tolerance and pain sensation during the surgery as well as the possible perception of light and colour sensations in minimally invasive vitrectomy under sub-tenon anesthesia shall be investigated.
Clinic for Ophthalmology, University Hospital RWTH Aachen
Aachen, Germany
Sensation of pain
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
Time frame: 1 Day
Discomfort
11-point numeric scale ranges from '0' (means "no discomfort") to '10' (means "worst discomfort imaginable"), Questionnaire
Time frame: 1 Day
Visual Sensations
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
Time frame: 1 Day
Chemosis
5-point numeric scale from '0' (means no chemosis) to 4 (means chemosis of all 4 eye quadrants), Questionnaire (surgeon)
Time frame: 1 Day
Eye movement
4-point numeric scale: '0' (means ptosis and no motility), '1' (mild motility), '2' (moderate motility), '3' (full motility), Questionnaire (surgeon)
Time frame: 1 Day
Surgeon's general feeling of comfort during the surgery
6-point numeric scale ranges from '1' (means best comfort conditions) to '6' (means worst comfort conditions) Questionnaire (surgeon)
Time frame: 1 Day
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