Comparative Study 23G Versus 27G Vitrectomy

NCT ID: NCT04216108

Last Updated: 2020-05-08

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-03-13

Brief Summary

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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

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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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23G gauge needle vitrectomy surgery

Group Type EXPERIMENTAL

Vitrectomy (23G gauge needle)

Intervention Type DEVICE

Vitrectomy surgery with 23G gauge needle technique

27G gauge needle vitrectomy surgery

Group Type EXPERIMENTAL

Vitrectomy (27G gauge needle)

Intervention Type DEVICE

Vitrectomy surgery with 27G gauge needle technique

Interventions

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Vitrectomy (23G gauge needle)

Vitrectomy surgery with 23G gauge needle technique

Intervention Type DEVICE

Vitrectomy (27G gauge needle)

Vitrectomy surgery with 27G gauge needle technique

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Peter Stalmans

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Peter Stalmans

Prof. Dr. Peter Stalmans

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Peter Stalmans, MD Phd

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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University Hospitals Leuven (UZ Leuven)

Leuven, Vl-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S61408

Identifier Type: -

Identifier Source: org_study_id

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