NCT00411970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 25, 2007

Status Verified

October 1, 2007

First QC Date

December 14, 2006

Last Update Submit

October 24, 2007

Conditions

Diabetic RetinopathyMacular EdemaPostoperative ComplicationsVitreous Hemorrhage

Keywords

23 gauge pars plana vitrectomyconjunctival erythema and injection20 gauge pars plana vitrectomyvitreous and retinal surgery

Outcome Measures

Primary Outcomes (2)

  • Conjunctival Injection

  • Subjective postoperative recovery

Secondary Outcomes (5)

  • Surgery time

  • Intraocular pressure

  • Visual acuity

  • Technically successful surgery (from surgeon's view)

  • Intra- and postoperative complications

Interventions

20- and 23 gauge vitreoretinal surgery systemsDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age
  • Written form of consent
  • Vitreous and retinal pathologies requiring surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

Vienna, 1030, Austria

Location

MeSH Terms

Conditions

Diabetic RetinopathyMacular EdemaPostoperative ComplicationsVitreous Hemorrhage

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesMacular DegenerationRetinal DegenerationPathologic ProcessesPathological Conditions, Signs and SymptomsEye HemorrhageHemorrhage

Study Officials

  • Susanne Binder, Prof. MD

    Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

    PRINCIPAL INVESTIGATOR

  • Lukas M Kellner, MD

    Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

    STUDY DIRECTOR

  • Barbara Wimpissinger, MD

    Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2006

First Posted

December 15, 2006

Study Start

September 1, 2004

Study Completion

October 1, 2007

Last Updated

October 25, 2007

Record last verified: 2007-10

Locations

AU(1)