20- Versus 23- Gauge System for Pars Plana Vitrectomy

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00411970

First Posted: December 15, 2006

Last Update Posted: October 25, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Purpose

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.

Condition	Intervention	Phase
Diabetic Retinopathy Macular Edema Postoperative Complications Vitreous Hemorrhage	Device: 20- and 23 gauge vitreoretinal surgery systems	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Treatment
Official Title:	20- Versus 23- Gauge System for Pars Plana Vitrectomy: A Prospective Randomized Clinical Study

Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:

Conjunctival Injection
Subjective postoperative recovery

Secondary Outcome Measures:

Surgery time
Intraocular pressure
Visual acuity
Technically successful surgery (from surgeon`s view)
Intra- and postoperative complications


Enrollment:	60
Study Start Date:	September 2004
Study Completion Date:	October 2007

Detailed Description:

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411970

Locations


Austria
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Vienna, Austria, 1030

Sponsors and Collaborators

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Investigators


Principal Investigator:	Susanne Binder, Prof. MD	Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Study Director:	Lukas M Kellner, MD	Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Study Chair:	Barbara Wimpissinger, MD	Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

More Information


ClinicalTrials.gov Identifier:	NCT00411970 History of Changes
Other Study ID Numbers:	23 versus 20 gauge
First Submitted:	December 14, 2006
First Posted:	December 15, 2006
Last Update Posted:	October 25, 2007
Last Verified:	October 2007

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:


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

Additional relevant MeSH terms:


Hemorrhage Macular Edema Diabetic Retinopathy Postoperative Complications Vitreous Hemorrhage Pathologic Processes Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications	Diabetes Mellitus Endocrine System Diseases Eye Hemorrhage Temazepam Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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