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Pressurized PPV 23GA Vitrectomy in Complicated Diabetic Tractional Retinal Detachment

Primary Purpose

Retinal Detachment

Status

Unknown status

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Vitrectomy

About this trial

This is an interventional treatment trial for Retinal Detachment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Complicated retinal detachment with no more than 6months of evolution

Exclusion Criteria:

Retinal detachments of more than 6 months of evolution No light perception

Sites / Locations

Asociación para Evitar la Ceguera en México, Hospital "Luis Sánchez Bulnes"Recruiting

Outcomes

Primary Outcome Measures

Perfluorocarbon liquids consumption

Secondary Outcome Measures

Full Information

NCT ID

NCT00404209

First Posted

June 30, 2006

Last Updated

November 29, 2007

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00404209

Brief Title

Pressurized PPV 23GA Vitrectomy in Complicated Diabetic Tractional Retinal Detachment

Official Title

Pressurized Perfluorocarbon Perfused 23 GA Vitrectomy in Complicated Diabetic Retinal Detachment

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2008 (Anticipated)

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 pressurized perfluorocarbon liquid (PCL) perfusion to remove vitreous during suction-cutting 23 GA vitrectomy using a dual, dynamic drive (3D)technology, in complicated retinal detachment surgeries.

6. Conditions and Keywords

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

Retinal Detachment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Vitrectomy

Intervention Description

pressurized 23GA vitrectomy with a 3D system

Primary Outcome Measure Information:

Title

Perfluorocarbon liquids consumption

Time Frame

two months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Complicated retinal detachment with no more than 6months of evolution Exclusion Criteria: Retinal detachments of more than 6 months of evolution No light perception

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 Mexico, Hospital "Luis Sanchez Bulnes"

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Raul Velez-Montoya, 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 México, Hospital "Luis Sánchez 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

Hugo Quiroz-Mercado, MD

Phone

5255 10841400

Ext

1171

retinamex@yahoo.com

First Name & Middle Initial & Last Name & Degree

Maria A Martinez-Castellanos, MD

First Name & Middle Initial & Last Name & Degree

Gerardo Garcia-Aguirre, MD

First Name & Middle Initial & Last Name & Degree

Orlando Ustariz-Gonzalez, 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

Pressurized PPV 23GA Vitrectomy in Complicated Diabetic Tractional Retinal Detachment

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