Transconjunctival Sutureless 25-Gauge Vitrectomy (TSV-25G)
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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 |
- 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 |
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| Brazil | |
| Hospital Oftalmologico de Brasilia | |
| Brasília, DF, Brazil, 70000 | |
| 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 June 18, 2013