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20- Versus 23- Gauge System for Pars Plana Vitrectomy
This study has been completed.
Sponsor:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00411970
First received: December 14, 2006
Last updated: October 24, 2007
Last verified: October 2007
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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 Blind 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 |
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| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00411970
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | December 14, 2006 |
| Last Updated: | October 24, 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 |
ClinicalTrials.gov processed this record on June 27, 2017