Comparative Study 27G Vitrectomy vs Larger Gauge Surgery

Two-arm, mono-center, prospective, interventional comparative case study to compare postoperative recovery between the 27G and larger gauge surgical approach.

Study Overview

• Status: Completed
• Conditions: Vitreoretinal Surgery
• Intervention / Treatment: Device: vitrectomy (27G gauge or larger needle)

Detailed Description

A prospective randomized comparison of postoperative recovery between 27-gauge and larger gauge surgical approaches to evaluate efficiencies and postoperative outcomes of the surgical gauges. Fifty patients who were scheduled to undergo pars plana vitrectomy (PPV) for floaters or macular surgery were treated with either 27-gauge or 23-gauge techniques and assessed for efficiency of the procedures as well as a variety of postop indicators of pain and inflammation.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen 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 (for the same eye)
• No prior inclusion in this trial
• Scheduled for vitrectomy for floater removal or macular surgery (including macular holes) without endotamponades such as PFCL, Gas, Silicone oil). (Air tamponade is allowed )

Exclusion Criteria:

• • Patients with serious heart, lung, liver, or kidney dysfunction

  • Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis, eyes with refraction >+5D or exceeding -8D , or other eye disease that impacts the outcome of vitrectomy surgery
  • Patients with HIV
  • Patients with history of drug abuse or alcoholism
  • Patients participating in other drug or medical device clinical trials before screening for this trial

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
Active Comparator: 27 gauge needle vitrectomy surgery; ultra-small gauge	Device: vitrectomy (27G gauge or larger needle); vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.; Other Names: vitrectomy surgery with 27G or larger needle technique
Active Comparator: larger than 27 gauge (23G or 25G) needle vitrectomy surgery; 23-gauge and 25-gauge instruments are a little larger in size	Device: vitrectomy (27G gauge or larger needle); vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.; Other Names: vitrectomy surgery with 27G or larger 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)	day 1 postoperative
changes in post-operative outcome of redness	scoring the amount of redness on a scale 0-4 through eye photos	day 1 postoperative
changes in post-operative outcome in grading of anterior chamber cells	clinical assessment by slit lamp examination (Tyndall 0-3 and Cells 0-3)	day 1 postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual acuity	best corrected visual acuity in LogMar will be obtained to report the visual acuity	day 1 postoperative
intra-ocular pressure	Millimeter of Mercury pressure (mmHg) will be measured to report the intra-ocular pressure	day 1 postoperative
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 postoperative

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Actual): January 23, 2021
• Study Completion (Actual): January 23, 2021

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: S63610

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