Transconjunctival Sutureless 25-Gauge Vitrectomy | NCT00870597

Studies
Transconjunctival Sutureless 25-Gauge Vitrectomy

NCT00870597

Sponsor

Hospital Oftalmologico de Brasilia

Status

Completed

Last Update Posted

Mar 27, 2009Estimated

Enrollment

14Actual

Phase

Phase 3

Conditions

Visual Acuity

Interventions

Multifocal IOL implantation + Vitrectomy
Multifocal IOL implantation - Vitrectomy

Countries

Brazil

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

Mar 2009

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

Jan 2007

Primary Completion Date

Feb 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Mar 26, 2009

First Submission Date that Met QC Criteria

Mar 26, 2009

First Posted Date

Mar 27, 2009Estimated

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

Mar 26, 2009

Last Update Posted Date

Mar 27, 2009Estimated

Name	Class
Federal University of Minas Gerais	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation.

Detailed Description

Purpose: The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation.

Setting: Hospital Oftalmológico de Brasília, Brasília, DF, Brazil.

Methods: Fourteen eyes of 11 patients with multifocal IOL implant associated with vitreous opacities that underwent 25-gauge vitrectomy were prospectively analyzed. Information collected included near and distance uncorrected visual acuity (UCDVA), best corrected distance visual acuity (BCDVA), and the spherical equivalent (SE) before and 3 months after vitrectomy. Patients were questioned about surgery satisfaction and visual improvement after vitrectomy.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Multifocal IOL implant associated with vitreous opacities that underwent 25-gauge vitrectomy were prospectively analyzed.	Procedure: Multifocal IOL implantation + Vitrectomy
2	Experimental	Multifocal IOL implantation without transconjunctival vitrectomy	Procedure: Multifocal IOL implantation - Vitrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multifocal IOL implantation + Vitrectomy	Procedure	25-gauge transconjuntival sutureless vitrectomy (TSV)	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

disabling vitreous floaters
Age-related cataract Unsatisfactory correction with glasses

Exclusion Criteria:

central endothelial cell count less than 2000 cells/mm2
glaucoma or intraocular pressure greater than 21 mmHg
amblyopia
retinal abnormalities
diabetes mellitus
steroid or immunosuppressive treatment
connective tissue diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 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
PATRICK TZELIKIS, PhD	Federal University of Minas Gerais	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Oftalmologico de Brasilia		Brasília	Federal District	70000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
C000726608	vitreous floaters

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014821	Vitrectomy

Ancestor Terms

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided