20- Versus 23- Gauge System for Pars Plana Vitrectomy

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Status and phase: Completed; Phase 4

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

Treatments: Device: 20- and 23 gauge vitreoretinal surgery systems

Study type: Interventional

Funder types: Other

Identifiers

NCT00411970

23 versus 20 gauge

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind