Text Size

20- Versus 23- Gauge System for Pars Plana Vitrectomy

This study has been completed.
Sponsor:
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
History of Changes
  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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Austria: Ethikkommission
Austria: Federal Ministry for Health and Women

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:
Diabetic Retinopathy
Edema
Hemorrhage
Macular Edema
Postoperative Complications
Retinal Diseases
Vitreous Hemorrhage
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Pathologic Processes
Macular Degeneration
Retinal Degeneration
Eye Hemorrhage

ClinicalTrials.gov processed this record on May 23, 2013