NCT00411970

20- Versus 23- Gauge System for Pars Plana Vitrectomy

20- Versus 23- Gauge System for Pars Plana Vitrectomy: A Prospective Randomized Clinical Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Retinopathy
• Macular Edema
• Postoperative Complications
• Vitreous Hemorrhage

Interventions

Type	Name	Description
DEVICE	20- and 23 gauge vitreoretinal surgery systems

Timeline

• Start date: 2004-09-01
• Completion: 2007-10-01
• First posted: 2006-12-15
• Last updated: 2007-10-25

Locations

1 site across 1 country: Austria