Comparative Study 27G Vitrectomy vs Larger Gauge Surgery

Not Applicable

Completed

• Conditions: Vitreoretinal Surgery
• Interventions: Device: vitrectomy (27G gauge or larger needle)

• Registration Number: NCT04412525
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-02
• Study Start: 2020-06-05
• Primary Completion: 2021-01-23
• Study Completion: 2021-01-23
• Status Verified: 2022-06
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
27 gauge needle vitrectomy surgery	vitrectomy (27G gauge or larger needle)	ultra-small gauge
larger than 27 gauge (23G or 25G) needle vitrectomy surgery	vitrectomy (27G gauge or larger needle)	23-gauge and 25-gauge instruments are a little larger in size

Primary Outcome Measures

Name	Time	Method
changes in post-operative outcome of pain	day 1 postoperative	by assessing the amount of pain on a visual analogue scale (score 0-9)
changes in post-operative outcome of redness	day 1 postoperative	scoring the amount of redness on a scale 0-4 through eye photos
changes in post-operative outcome in grading of anterior chamber cells	day 1 postoperative	clinical assessment by slit lamp examination (Tyndall 0-3 and Cells 0-3)

Secondary Outcome Measures

Name	Time	Method
intra-ocular pressure	day 1 postoperative	Millimeter of Mercury pressure (mmHg) will be measured to report the intra-ocular pressure
visual acuity	day 1 postoperative	best corrected visual acuity in LogMar will be obtained to report the visual acuity
pain-assessment	1 week postoperative	a questionnaire with visual analogue scale will be used to assess the level of pain up to 1 week after the operation

Trial Locations

Locations (1)

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Belgium