Comparative Study 23G Versus 27G Vitrectomy (23Gvs27G)

Prof. Dr. Peter Stalmans

Status

Completed

Conditions

Vitreoretinal Surgery

Treatments

Device: Vitrectomy (27G gauge needle)

Device: Vitrectomy (23G gauge needle)

Study type

Interventional

Funder types

Other

Identifiers

NCT04216108

S61408

Details and patient eligibility

About

Investigator-initiated, comparative double-arm, mono-center, prospective, interventional case study to determine whether ultra-small gauge surgery (27G gauge needle) improves postoperative outcome and patient morbidity.

Enrollment

80 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
No prior inclusion in this trial
Scheduled for vitrectomy for floater removal or macular surgery

Exclusion criteria

Patients with serious heart, lung, liver, or kidney dysfunction
Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis and other eye disease that impacts the outcome of vitrectomy surgery Patients with HIV (Human Immune-deficiency Virus)
Patients with history of drug abuse or alcoholism
Patients participating in other drug or medical device clinical trials before screening for this trial
Pregnancy, preparation for pregnancy during clinical trial, or breastfeeding
Belief by the investigator that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression