Comparative Study 27G Vitrectomy vs Larger Gauge Surgery

NCT ID: NCT04412525

Last Updated: 2022-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-05

Study Completion Date

2021-01-23

Brief Summary

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

Detailed Description

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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.

Conditions

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Vitreoretinal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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27 gauge needle vitrectomy surgery

ultra-small gauge

Group Type ACTIVE_COMPARATOR

vitrectomy (27G gauge or larger needle)

Intervention Type DEVICE

vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.

larger than 27 gauge (23G or 25G) needle vitrectomy surgery

23-gauge and 25-gauge instruments are a little larger in size

Group Type ACTIVE_COMPARATOR

vitrectomy (27G gauge or larger needle)

Intervention Type DEVICE

vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.

Interventions

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vitrectomy (27G gauge or larger needle)

vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.

Intervention Type DEVICE

Other Intervention Names

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vitrectomy surgery with 27G or larger needle technique

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Stalmans, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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S63610

Identifier Type: -

Identifier Source: org_study_id

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