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

This study has been completed.
Sponsor:
Collaborator:
Federal University of Minas Gerais
Information provided by:
Hospital Oftalmologico de Brasilia
ClinicalTrials.gov Identifier:
NCT00870597
First received: March 26, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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.


Condition Intervention Phase
Visual Acuity
Procedure: Multifocal IOL implantation + Vitrectomy
Procedure: Multifocal IOL implantation - Vitrectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Transconjunctival Sutureless 25-Gauge Vitrectomy for Visually Significant Vitreous Floaters in Patients With Multifocal Intraocular Lens

Further study details as provided by Hospital Oftalmologico de Brasilia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: January 2007
Study Completion Date: December 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: VITRECTOMY
Experimental: 2
Multifocal IOL implantation without transconjunctival vitrectomy
Procedure: Multifocal IOL implantation - Vitrectomy
Multifocal IOL implantation without transconjunctival vitrectomy

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870597

Locations
Brazil
Hospital Oftalmologico de Brasilia
Brasília, DF, Brazil, 70000
Sponsors and Collaborators
Hospital Oftalmologico de Brasilia
Federal University of Minas Gerais
Investigators
Principal Investigator: PATRICK TZELIKIS, PhD Federal University of Minas Gerais
  More Information

No publications provided

Responsible Party: PATRICK TZELIKIS, UNIVERSIDADE FEDERAL DE MINAS GERAIS
ClinicalTrials.gov Identifier: NCT00870597     History of Changes
Other Study ID Numbers: HOB-03
Study First Received: March 26, 2009
Last Updated: March 26, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Oftalmologico de Brasilia:
Floaters
multifocal IOL
visual complaints
vitrectomy

ClinicalTrials.gov processed this record on September 15, 2014