Safety and Feasibility of Sutureless Pars-plana Vitrectomy in Sub-Tenon Anesthesia

Vitreoretinal Diseases Clinical Trial

— SAFE-VISA  

Official title:

A Prospective, One-center Clinical Trial to Identify the Safety and Feasibility of Sutureless Pars-plana Vitrectomy Performed in Sub-tenon Anesthesia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04257188
• Other study ID #: 19-169
• Status: Completed
• Start date: November 7, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitreoretinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	Clinic for Ophthalmology, University Hospital RWTH Aachen	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Discomfort	11-point numeric scale ranges from '0' (means "no discomfort") to '10' (means "worst discomfort imaginable"), Questionnaire	1 Day
Primary	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	Chemosis	5-point numeric scale from '0' (means no chemosis) to 4 (means chemosis of all 4 eye quadrants), Questionnaire (surgeon)	1 Day
Secondary	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
Secondary	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