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20- Versus 23- Gauge System for Pars Plana Vitrectomy

NCT ID: NCT00411970

Last Updated: 2007-10-25

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

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-10-31

Brief Summary

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The aim of the present study is to compare the functional and clinical differences and advantages between a standard operating system and a newly developed even smaller system for pars plana vitrectomy.

The present study may work out the possible advantages and disadvantages between the routinely used 20-gauge vitrectomy system and the newly developed 23-gauge device.

Detailed Description

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60 patient randomized into 2 groups of 30 each. All of them operated in general anesthesia, vitrectomized and cataract extracted by phacoemulsification if indicated. Preoperative and postoper5ative controls at days 1,2,3 and week 1, month 1,3 and 12 performed. Parameters of interest are: postoperative conjunctival injection, pain, eye pressure, complications intra- and postoperative as well as the durations of surgery divided into opening time, vitrectomy time, retinal manipulation time, closing time.

Conditions

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Diabetic Retinopathy Macular Edema Postoperative Complications Vitreous Hemorrhage

Keywords

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23 gauge pars plana vitrectomy conjunctival erythema and injection 20 gauge pars plana vitrectomy vitreous and retinal surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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20- and 23 gauge vitreoretinal surgery systems

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Over 18 years of age
* Written form of consent
* Vitreous and retinal pathologies requiring surgery

Exclusion Criteria

* Previous history of vitreous or retinal surgery
* Pregnant or breastfeeding women
* Prohibiting general medical conditions or diseases
* No informed consent signed
* Under 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

OTHER

Sponsor Role lead

Principal Investigators

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Susanne Binder, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

Lukas M Kellner, MD

Role: STUDY_DIRECTOR

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

Barbara Wimpissinger, MD

Role: STUDY_CHAIR

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

Locations

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Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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23 versus 20 gauge

Identifier Type: -

Identifier Source: org_study_id