Safety and Feasibility of Sutureless Pars-plana Vitrectomy in Sub-Tenon Anesthesia (SAFE-VISA)

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.

Study Overview

• Status: Completed
• Conditions: Vitreoretinal Diseases
• Intervention / Treatment: Procedure: minimally invasive vitrectomy under subtenon anaesthesia

Detailed Description

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 (Actual): 67

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52066
    • Clinic for Ophthalmology, University Hospital RWTH Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population is acquired from the patient collective of the eye clinic of the University Hospital Aachen and have a medical indication for vitrectomy, which is independent of study participation.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
minimally invasive vitrectomy under subtenon anaesthesia	Procedure: minimally invasive vitrectomy under subtenon anaesthesia; 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.
minimally invasive vitrectomy under general anaesthesia	Procedure: minimally invasive vitrectomy under subtenon anaesthesia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensation of pain	11-point numeric scale ranges from '0' (means "no pain") to '10' (means "worst pain imaginable"), Questionnaire; Wong-Baker FACES® Scale (6 Faces, range no hurt - hurts worst), Questionnaire	1 Day
Discomfort	11-point numeric scale ranges from '0' (means "no discomfort") to '10' (means "worst discomfort imaginable"), Questionnaire	1 Day
Visual Sensations	4 questions, Likert scale ("yes", "no", "don't know/not sure"), Questionnaire; perception of details during surgery (instruments, surgeon's face); perception of colors during surgery; perception of lights or shadows; no light perception at all during surgery	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemosis	5-point numeric scale from '0' (means no chemosis) to 4 (means chemosis of all 4 eye quadrants), Questionnaire (surgeon)	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)	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)	1 Day

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Antonis Koutsonas, Dr. med., Clinic for Ophthalmology, University Hospital RWTH Aachen

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Vitrectomy; Sub-tenon Anesthesia; Sutureless vitrectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 19-169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No