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

NCT04257188 | Completed

• 1 other identifier: 19-169
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitreoretinal Diseases

Keywords

Sub-tenon Anesthesia; Vitrectomy; Sutureless vitrectomy

Outcome Measures

Primary Outcomes (3)

• 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

  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 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

  1 Day

Secondary Outcomes (3)

• Chemosis

  1 Day

• Eye movement

  1 Day

• Surgeon's general feeling of comfort during the surgery

  1 Day

Study Arms (2)

minimally invasive vitrectomy under subtenon anaesthesia

Procedure: minimally invasive vitrectomy under subtenon anaesthesia

minimally invasive vitrectomy under general anaesthesia

Procedure: minimally invasive vitrectomy under subtenon anaesthesia

Interventions

minimally invasive vitrectomy under subtenon anaesthesia PROCEDURE

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; minimally invasive vitrectomy under subtenon anaesthesia

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Clinic for Ophthalmology, University Hospital RWTH Aachen

Aachen, 52066, Germany

Location

Related Publications (1)

• Lohmann T, Baumgarten S, Prinz J, Walter P, Koutsonas A. Safety and feasibility of sutureless pars-plana vitrectomy in sub-Tenon anesthesia (SAFE-VISA): a prospective study. Eur J Med Res. 2023 Oct 30;28(1):472. doi: 10.1186/s40001-023-01447-2.

  PMID: 37899488 DERIVED

Study Officials

• Antonis Koutsonas, Dr. med.

  Clinic for Ophthalmology, University Hospital RWTH Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Antonis Koutsonas

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: February 5, 2020
• Study Start: November 7, 2019
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)