20- Versus 23- Gauge System for Pars Plana Vitrectomy

Phase 4

Completed

• Conditions: Diabetic Retinopathy; Macular Edema; Postoperative Complications; Vitreous Hemorrhage

• Registration Number: NCT00411970
• Lead Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2006-12-14
• Study First Submitted QC: 2006-12-14
• Study First Posted: 2006-12-15
• Status Verified: 2007-10
• Study Completion: 2007-10
• Last Update Submitted: 2007-10-24
• Last Update Posted: 2007-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Conjunctival Injection
Subjective postoperative recovery

Secondary Outcome Measures

Name	Time	Method
Surgery time
Intraocular pressure
Visual acuity
Technically successful surgery (from surgeon's view)
Intra- and postoperative complications

Trial Locations

Locations (1)

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery; 🇦🇹 Vienna, Austria