20- Versus 23- Gauge System for Pars Plana Vitrectomy | NCT00411970

Studies
20- Versus 23- Gauge System for Pars Plana Vitrectomy

NCT00411970

Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Status

Completed

Last Update Posted

Oct 25, 2007Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Diabetic Retinopathy
Macular Edema
Postoperative Complications
Vitreous Hemorrhage

Interventions

20- and 23 gauge vitreoretinal surgery systems

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Dec 14, 2006

First Submission Date that Met QC Criteria

Dec 14, 2006

First Posted Date

Dec 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2007

Last Update Posted Date

Oct 25, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryOTHER

Collaborators

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Name	Type	Description	Arm Group Labels	Other Names
20- and 23 gauge vitreoretinal surgery systems	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Conjunctival Injection
Subjective postoperative recovery

Secondary Outcomes

Measure	Description	Time Frame
Surgery time
Intraocular pressure
Visual acuity

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery		Vienna		1030	Austria

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy
D008269	Macular Edema
D011183	Postoperative Complications
D014823	Vitreous Hemorrhage

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided