Clinical trial NCT04257188: Safety and Feasibility of Sutureless Pars-plana Vitrectomy in Sub-Tenon Anesthesia
Official title: A Prospective, One-center Clinical Trial to Identify the Safety and Feasibility of Sutureless Pars-plana Vitrectomy Performed in Sub-tenon Anesthesia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitreoretinal Diseases
Keywords: Sub-tenon Anesthesia
Vitrectomy
Sutureless vitrectomy
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 67
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Sensation of pain
timeFrame: 1 Day
measure: Discomfort
timeFrame: 1 Day
measure: Visual Sensations
timeFrame: 1 Day
Secondary outcomes:
measure: Chemosis
timeFrame: 1 Day
measure: Eye movement
timeFrame: 1 Day
measure: Surgeon's general feeling of comfort during the surgery
timeFrame: 1 Day
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Clinic for Ophthalmology, University Hospital RWTH Aachen
Study officials:
affiliation: Clinic for Ophthalmology, University Hospital RWTH Aachen
name: Antonis Koutsonas, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: