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Perfluorocarbon Perfused Vitrectomy and 3D Vitrectomy System in Advanced Diabetic Retinopathy

Primary Purpose

Diabetic Retinopathy

Status

Unknown status

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Vitrectomy

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring vitreoretinal surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Advanced diabetic retinopathy with retinal detachment

Exclusion Criteria:

Retinal detachments of more than 6 months

Sites / Locations

Asociación para Evitar la Ceguera en Mexico, Hospital "Luis Sanchez Bulnes"Recruiting

Outcomes

Primary Outcome Measures

Surgical time

Facility of surgical maneuvers

Secondary Outcome Measures

Full Information

NCT ID

NCT00407108

First Posted

June 30, 2006

Last Updated

December 5, 2006

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00407108

Brief Title

Perfluorocarbon Perfused Vitrectomy and 3D Vitrectomy System in Advanced Diabetic Retinopathy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Unknown status

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

5. Study Description

Brief Summary

To investigate the feasibility and advantages of using perfluorocarbon liquid (PCL) perfusion to remove vitreous during suction-cutting vitrectomy using a dual, dynamic drive (3D)technology. In complicated surgeries in advanced diabetic retinopathy and retinal detachment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy

Keywords

vitreoretinal surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Vitrectomy

Primary Outcome Measure Information:

Title

Surgical time

Title

Facility of surgical maneuvers

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Advanced diabetic retinopathy with retinal detachment Exclusion Criteria: Retinal detachments of more than 6 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hugo Quiroz-Mercado, MD

Phone

5255 10841400

Ext

1171

retinamex@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hugo Quiroz-Mercado, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asociación para Evitar la Ceguera en Mexico, Hospital "Luis Sanchez Bulnes"

City

Mexico City

State/Province

Mexico DF

ZIP/Postal Code

04030

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria A Martínez-Cstellanos, MD

Phone

52 55 10841400

Ext

1171

retinamex@yahoo.com

First Name & Middle Initial & Last Name & Degree

Hugo Quiroz-Mercado, MD

First Name & Middle Initial & Last Name & Degree

María A Martinez-Castellanos, MD

First Name & Middle Initial & Last Name & Degree

Gerardo García-Aguirre, MD

First Name & Middle Initial & Last Name & Degree

Orlando Ustariz-González, MD

First Name & Middle Initial & Last Name & Degree

Jose L Guerrero-Naranjo, MD

First Name & Middle Initial & Last Name & Degree

Jans Fromow-Guerra, MD

12. IPD Sharing Statement

Learn more about this trial

Perfluorocarbon Perfused Vitrectomy and 3D Vitrectomy System in Advanced Diabetic Retinopathy

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