NCT00870597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
Last Updated

March 27, 2009

Status Verified

March 1, 2009

Enrollment Period

1.1 years

First QC Date

March 26, 2009

Last Update Submit

March 26, 2009

Conditions

Visual Acuity

Keywords

Floatersmultifocal IOLvisual complaintsvitrectomy

Outcome Measures

Primary Outcomes (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

Study Arms (2)

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

Multifocal IOL implantation - VitrectomyPROCEDURE

Multifocal IOL implantation without transconjunctival vitrectomy

2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • disabling vitreous floaters
  • Age-related cataract Unsatisfactory correction with glasses

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Oftalmologico de Brasilia

Brasília, Federal District, 70000, Brazil

Location

MeSH Terms

Conditions

vitreous floaters

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • PATRICK TZELIKIS, PhD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

January 1, 2007

Primary Completion

February 1, 2008

Study Completion

December 1, 2008

Last Updated

March 27, 2009

Record last verified: 2009-03

Locations

BR(1)