Transconjunctival Sutureless 25-Gauge Vitrectomy

NCT ID: NCT00870597

Last Updated: 2009-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Visual Acuity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Multifocal IOL implant associated with vitreous opacities that underwent 25-gauge vitrectomy were prospectively analyzed.

Group Type EXPERIMENTAL

Multifocal IOL implantation + Vitrectomy

Intervention Type PROCEDURE

25-gauge transconjuntival sutureless vitrectomy (TSV)

2

Multifocal IOL implantation without transconjunctival vitrectomy

Group Type EXPERIMENTAL

Multifocal IOL implantation - Vitrectomy

Intervention Type PROCEDURE

Multifocal IOL implantation without transconjunctival vitrectomy

Interventions

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Multifocal IOL implantation + Vitrectomy

25-gauge transconjuntival sutureless vitrectomy (TSV)

Intervention Type PROCEDURE

Multifocal IOL implantation - Vitrectomy

Multifocal IOL implantation without transconjunctival vitrectomy

Intervention Type PROCEDURE

Other Intervention Names

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VITRECTOMY

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role collaborator

Hospital Oftalmologico de Brasilia

OTHER

Sponsor Role lead

Responsible Party

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UNIVERSIDADE FEDERAL DE MINAS GERAIS

Principal Investigators

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PATRICK TZELIKIS, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

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Hospital Oftalmologico de Brasilia

Brasília, Federal District, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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HOB-03

Identifier Type: -

Identifier Source: org_study_id

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