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NCT00411970 Clinical Trial

20- Versus 23- Gauge System for Pars Plana Vitrectomy

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00411970
Other study ID # 23 versus 20 gauge
Secondary ID
Status Completed
Phase Phase 4
First received December 14, 2006
Last updated October 24, 2007
Start date September 2004
Est. completion date October 2007

Study information
Verified date October 2007
Source The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Contact n/a
Is FDA regulated No
Health authority Austria: EthikkommissionAustria: Federal Ministry for Health and Women
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• 20- and 23 gauge vitreoretinal surgery systems

Locations
Country Name City State
Austria Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery Vienna

Sponsors (1)
Lead Sponsor Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Conjunctival Injection
Primary Subjective postoperative recovery
Secondary Surgery time
Secondary Intraocular pressure
Secondary Visual acuity
Secondary Technically successful surgery (from surgeon`s view)
Secondary Intra- and postoperative complications
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