Back to results20- Versus 23- Gauge System for Pars Plana Vitrectomy
Primary Purpose
Diabetic Retinopathy, Macular Edema, Postoperative Complications
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
20- and 23 gauge vitreoretinal surgery systems
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring 23 gauge pars plana vitrectomy, conjunctival erythema and injection, 20 gauge pars plana vitrectomy, vitreous and retinal surgery
Eligibility 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
Sites / Locations
- Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Outcomes
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
Full Information
NCT ID
NCT00411970
First Posted
December 14, 2006
Last Updated
October 24, 2007
Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
1. Study Identification
Unique Protocol Identification Number
NCT00411970
Brief Title
20- Versus 23- Gauge System for Pars Plana Vitrectomy
Official Title
20- Versus 23- Gauge System for Pars Plana Vitrectomy: A Prospective Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Macular Edema, Postoperative Complications, Vitreous Hemorrhage
Keywords
23 gauge pars plana vitrectomy, conjunctival erythema and injection, 20 gauge pars plana vitrectomy, vitreous and retinal surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
20- and 23 gauge vitreoretinal surgery systems
Primary Outcome Measure Information:
Title
Conjunctival Injection
Title
Subjective postoperative recovery
Secondary Outcome Measure Information:
Title
Surgery time
Title
Intraocular pressure
Title
Visual acuity
Title
Technically successful surgery (from surgeon's view)
Title
Intra- and postoperative complications
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Binder, Prof. MD
Organizational Affiliation
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lukas M Kellner, MD
Organizational Affiliation
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Barbara Wimpissinger, MD
Organizational Affiliation
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
City
Vienna
ZIP/Postal Code
1030
Country
Austria
12. IPD Sharing Statement
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20- Versus 23- Gauge System for Pars Plana Vitrectomy
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