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NCT Number: NCT00411970

20- Versus 23- Gauge System for Pars Plana Vitrectomy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

Vienna, 1030, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

20- and 23 gauge vitreoretinal surgery systems

Device

Primary outcomes

  1. Conjunctival Injection

  2. Subjective postoperative recovery

Secondary outcomes

  1. Surgery time

  2. Intraocular pressure

  3. Visual acuity

  4. Technically successful surgery (from surgeon's view)

  5. Intra- and postoperative complications

Sponsors and collaborators

Lead sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
Dec 15, 2006
Registry last updated
Oct 25, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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