20- Versus 23- Gauge System for Pars Plana Vitrectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

December 14, 2006

Last Updated Date

October 24, 2007

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Conjunctival Injection
Subjective postoperative recovery

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00411970 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

20- Versus 23- Gauge System for Pars Plana Vitrectomy

Official Title ^ICMJE

20- Versus 23- Gauge System for Pars Plana Vitrectomy: A Prospective Randomized Clinical Study

Brief Summary

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Diabetic Retinopathy
Macular Edema
Postoperative Complications
Vitreous Hemorrhage

Intervention ^ICMJE

Device: 20- and 23 gauge vitreoretinal surgery systems

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT ID ^ICMJE

NCT00411970

Responsible Party

Study ID Numbers ^ICMJE

23 versus 20 gauge

Study Sponsor ^ICMJE

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP