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)
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1
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000