20- Versus 23- Gauge System for Pars Plana Vitrectomy

October 24, 2007 updated by: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Conjunctival Injection
Subjective postoperative recovery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

December 14, 2006

First Submitted That Met QC Criteria

December 14, 2006

First Posted (Estimate)

December 15, 2006

Study Record Updates

Last Update Posted (Estimate)

October 25, 2007

Last Update Submitted That Met QC Criteria

October 24, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23 versus 20 gauge

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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