Comparative Study 23G Versus 27G Vitrectomy (23Gvs27G)

Investigator-initiated, comparative double-arm, mono-center, prospective, interventional case study to determine whether ultra-small gauge surgery (27G gauge needle) improves postoperative outcome and patient morbidity.

Study Overview

• Status: Completed
• Conditions: Vitreoretinal Surgery
• Intervention / Treatment: Device: Vitrectomy (23G gauge needle); Device: Vitrectomy (27G gauge needle)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vl-Brabant
    • Leuven, Vl-Brabant, Belgium, 3000
      • University Hospitals Leuven (UZ Leuven)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged over 18
• No prior vitrectomy surgery in the study eye
• No prior inclusion in this trial
• Scheduled for vitrectomy for floater removal or macular surgery

Exclusion Criteria:

• Patients with serious heart, lung, liver, or kidney dysfunction
• Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis and other eye disease that impacts the outcome of vitrectomy surgery Patients with HIV (Human Immune-deficiency Virus)
• Patients with history of drug abuse or alcoholism
• Patients participating in other drug or medical device clinical trials before screening for this trial
• Pregnancy, preparation for pregnancy during clinical trial, or breastfeeding
• Belief by the investigator that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 23G gauge needle vitrectomy surgery	Device: Vitrectomy (23G gauge needle); Vitrectomy surgery with 23G gauge needle technique
Experimental: 27G gauge needle vitrectomy surgery	Device: Vitrectomy (27G gauge needle); Vitrectomy surgery with 27G gauge needle technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in post-operative outcome of pain	By assessing the amount of pain on a visual analogue scale (score 0 - 9)	1 week
Changes in post-operative outcome of redness	Scoring the amount of redness on a scale 0-4 through eye photos	1 week
Changes in post-operative outcome of measured inflammation	Measuring the amount of inflammation by measurement of Flare (photon/ms)	1 week
Changes in post-operative outcome in grading of anterior chamber cells	Clinical assesment by slit lamp (Tyndall 0 - 3 and Cells 0 - 3)	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative parameter: Visual acuity	Best corrected visual acuity in LogMar will be obtained to report the visual acuity.	1 week
Post-operative parameter: Intraocular pressure	Millimeter of Mercury pressure (mmHG) will be measured to report the intraocular pressure.	1 week
Post-operative parameter: Pain assessment	A questionnaire with visual analogue scale will be used to assess the level of pain up to 1 week after the operation	1 week

Collaborators and Investigators

• Sponsor: Prof. Dr. Peter Stalmans

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): March 5, 2020
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: S61408

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No