Transconjunctival Sutureless 25-Gauge Vitrectomy (TSV-25G)

March 26, 2009 updated by: Hospital Oftalmologico de Brasilia

Transconjunctival Sutureless 25-Gauge Vitrectomy for Visually Significant Vitreous Floaters in Patients With Multifocal Intraocular Lens

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • DF
      • Brasília, DF, Brazil, 70000
        • Hospital Oftalmologico de Brasilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Multifocal IOL implant associated with vitreous opacities that underwent 25-gauge vitrectomy were prospectively analyzed.
Procedure: Multifocal IOL implantation + Vitrectomy
25-gauge transconjuntival sutureless vitrectomy (TSV)
Other Names:
  • VITRECTOMY
EXPERIMENTAL: 2
Multifocal IOL implantation without transconjunctival vitrectomy
Procedure: Multifocal IOL implantation - Vitrectomy
Multifocal IOL implantation without transconjunctival vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Oftalmologico de Brasilia

Collaborators

Federal University of Minas Gerais

Investigators

  • Principal Investigator: PATRICK TZELIKIS, PhD, Federal University of Minas Gerais

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (ESTIMATE)

March 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 27, 2009

Last Update Submitted That Met QC Criteria

March 26, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HOB-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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