Transconjunctival Sutureless 25-Gauge Vitrectomy

Visual Acuity Clinical Trial

— TSV-25G  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870597
• Other study ID #: HOB-03
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2009
• Last updated: March 26, 2009
• Start date: January 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: Hospital Oftalmologico de Brasilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Procedure:
• Multifocal IOL implantation + Vitrectomy
25-gauge transconjuntival sutureless vitrectomy (TSV)
• Multifocal IOL implantation - Vitrectomy
Multifocal IOL implantation without transconjunctival vitrectomy

Locations

Country	Name	City	State
Brazil	Hospital Oftalmologico de Brasilia	Brasília	DF

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Oftalmologico de Brasilia	Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes