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| Sponsored by: |
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 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | 20- Versus 23- Gauge System for Pars Plana Vitrectomy: A Prospective Randomized Clinical Study |
| 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | 23 versus 20 gauge |
| Study First Received: | December 14, 2006 |
| Last Updated: | October 24, 2007 |
| ClinicalTrials.gov Identifier: | NCT00411970 |
| Health Authority: | Austria: Ethikkommission; Austria: Federal Ministry for Health and Women |
|
23 gauge pars plana vitrectomy conjunctival erythema and injection 20 gauge pars plana vitrectomy vitreous and retinal surgery |
|
Erythema Eye Diseases Temazepam Vascular Diseases Diabetes Mellitus Retinal Degeneration Macular Degeneration Endocrine System Diseases Edema Hemorrhage |
Vitreous Hemorrhage Diabetic Angiopathies Macular Edema Diabetic Retinopathy Postoperative Complications Endocrinopathy Retinal Diseases Diabetes Complications Retinal degeneration |
|
Pathologic Processes Eye Hemorrhage Cardiovascular Diseases |
