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Pressurized PPV 23GA Vitrectomy in Complicated Diabetic Tractional Retinal Detachment
This study is currently recruiting participants.
Verified by Asociación para Evitar la Ceguera en México, November 2007
Sponsored by: Asociación para Evitar la Ceguera en México
Information provided by: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT00404209
  Purpose

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.


Condition Intervention Phase
Retinal Detachment
Procedure: Vitrectomy
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Pressurized Perfluorocarbon Perfused 23 GA Vitrectomy in Complicated Diabetic Retinal Detachment

Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • Perfluorocarbon liquids consumption [ Time Frame: two months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2007
Estimated Study Completion Date: February 2008
Intervention Details:
    Procedure: Vitrectomy
    pressurized 23GA vitrectomy with a 3D system
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404209

Contacts
Contact: Hugo Quiroz-Mercado, MD 5255 10841400 ext 1171 retinamex@yahoo.com

Locations
Mexico, Mexico DF
Asociación para Evitar la Ceguera en México, Hospital "Luis Sánchez Bulnes" Recruiting
Mexico City, Mexico DF, Mexico, 04030
Contact: Hugo Quiroz-Mercado, MD     5255 10841400 ext 1171     retinamex@yahoo.com    
Sub-Investigator: Maria A Martinez-Castellanos, MD            
Sub-Investigator: Gerardo Garcia-Aguirre, MD            
Sub-Investigator: Orlando Ustariz-Gonzalez, MD            
Sub-Investigator: Jose L Guerrero-Naranjo, MD            
Sub-Investigator: Jans Fromow-Guerra, MD            
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Hugo Quiroz-Mercado, MD Asociación para Evitar la Ceguera en Mexico, Hospital "Luis Sanchez Bulnes"
Principal Investigator: Raul Velez-Montoya, MD Asociacion para Evitar la Ceguera en Mexico
  More Information

Responsible Party: Asociacion para evitar la ceguera en Mexico ( Hugo Quiroz-Mercado )
Study ID Numbers: APEC-008
Study First Received: June 30, 2006
Last Updated: November 29, 2007
ClinicalTrials.gov Identifier: NCT00404209  
Health Authority: Mexico: Ministry of Health

Study placed in the following topic categories:
Retinal Detachment
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on January 14, 2009