Status:

COMPLETED

Comparative Study 27G Vitrectomy vs Larger Gauge Surgery

Lead Sponsor:

Universitaire Ziekenhuizen KU Leuven

Conditions:

Vitreoretinal Surgery

Eligibility:

All Genders

18+ years

Phase:

NA

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 pa...

Eligibility Criteria

Inclusion

  • 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

  • • 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

Key Trial Info

Start Date :

June 5 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 23 2021

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT04412525

Start Date

June 5 2020

End Date

January 23 2021

Last Update

July 11 2022

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Universitaire Ziekenhuizen Leuven

Leuven, Belgium, 3000