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
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Retinopathy Macular Edema Postoperative Complications Vitreous Hemorrhage | Device: 20- and 23 gauge vitreoretinal surgery systems | Phase 4 |
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 |
- Conjunctival Injection
- Subjective postoperative recovery
- Surgery time
- Intraocular pressure
- Visual acuity
- Technically successful surgery (from surgeon`s view)
- Intra- and postoperative complications

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

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