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TSV-25G: Transconjunctival Sutureless 25-Gauge Vitrectomy

Sponsor
Hospital Oftalmologico de Brasilia (Other)
Overall Status
Completed
CT.gov ID
NCT00870597
Collaborator
Federal University of Minas Gerais (Other)
14
Enrollment
1
Location
2
Arms
23
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Multifocal IOL implantation + Vitrectomy
  • Procedure: Multifocal IOL implantation - Vitrectomy
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Transconjunctival Sutureless 25-Gauge Vitrectomy for Visually Significant Vitreous Floaters in Patients With Multifocal Intraocular Lens
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Feb 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00870597
    Other Study ID Numbers:
    • HOB-03
    First Posted:
    Mar 27, 2009
    Last Update Posted:
    Mar 27, 2009
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    Floaters
    multifocal IOL
    visual complaints
    vitrectomy

    Study Results

    No Results Posted as of Mar 27, 2009