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20- Versus 23- Gauge System for Pars Plana Vitrectomy

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ClinicalTrials.gov Identifier: NCT00411970
Recruitment Status : Completed
First Posted : December 15, 2006
Last Update Posted : October 25, 2007
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : September 2004
Actual Study Completion Date : October 2007
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Primary Outcome Measures :
  1. Conjunctival Injection
  2. Subjective postoperative recovery

Secondary Outcome Measures :
  1. Surgery time
  2. Intraocular pressure
  3. Visual acuity
  4. Technically successful surgery (from surgeon`s view)
  5. Intra- and postoperative complications

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00411970     History of Changes
Other Study ID Numbers: 23 versus 20 gauge
First Posted: December 15, 2006    Key Record Dates
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