20- Versus 23- Gauge System for Pars Plana Vitrectomy

Condition(s) targeted: Diabetic Retinopathy; Macular Edema; Postoperative Complications; Vitreous Hemorrhage

Intervention: 20- and 23 gauge vitreoretinal surgery systems (Device)

Phase: Phase 4

Status: Completed

Sponsored by: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Official(s) and/or principal investigator(s):
Susanne Binder, Prof. MD, Principal Investigator, Affiliation: Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Lukas M Kellner, MD, Study Director, Affiliation: Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Barbara Wimpissinger, MD, Study Chair, Affiliation: Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

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.

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

Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

Conjunctival Injection

Subjective postoperative recovery

Secondary outcome:

Surgery time

Intraocular pressure

Visual acuity

Technically successful surgery (from surgeon`s view)

Intra- and postoperative complications

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery, Vienna 1030, Austria

Starting date: September 2004
Ending date: October 2007
Last updated: October 24, 2007