Comparative Study 23G Versus 27G Vitrectomy

Not Applicable

Completed

• Conditions: Vitreoretinal Surgery
• Interventions: Device: Vitrectomy (27G gauge needle); Device: Vitrectomy (23G gauge needle)

• Registration Number: NCT04216108
• Lead Sponsor: Prof. Dr. Peter Stalmans

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Primary Completion: 2020-03-05
• Study Completion: 2020-03-13
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
27G gauge needle vitrectomy surgery	Vitrectomy (27G gauge needle)	-
23G gauge needle vitrectomy surgery	Vitrectomy (23G gauge needle)	-

Primary Outcome Measures

Name	Time	Method
Changes in post-operative outcome of redness	1 week	Scoring the amount of redness on a scale 0-4 through eye photos
Changes in post-operative outcome of pain	1 week	By assessing the amount of pain on a visual analogue scale (score 0 - 9)
Changes in post-operative outcome of measured inflammation	1 week	Measuring the amount of inflammation by measurement of Flare (photon/ms)
Changes in post-operative outcome in grading of anterior chamber cells	1 week	Clinical assesment by slit lamp (Tyndall 0 - 3 and Cells 0 - 3)

Secondary Outcome Measures

Name	Time	Method
Post-operative parameter: Visual acuity	1 week	Best corrected visual acuity in LogMar will be obtained to report the visual acuity.
Post-operative parameter: Pain assessment	1 week	A questionnaire with visual analogue scale will be used to assess the level of pain up to 1 week after the operation
Post-operative parameter: Intraocular pressure	1 week	Millimeter of Mercury pressure (mmHG) will be measured to report the intraocular pressure.

Trial Locations

Locations (1)

University Hospitals Leuven (UZ Leuven); 🇧🇪 Leuven, Vl-Brabant, Belgium