Comparative Study 27G Vitrectomy vs Larger Gauge Surgery

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

Vitreoretinal Surgery

Treatments

Device: vitrectomy (27G gauge or larger needle)

Study type

Interventional

Funder types

Other

Identifiers

NCT04412525

S63610

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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