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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00407108
Recruitment Status : Unknown
Verified November 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
First Posted : December 4, 2006
Last Update Posted : December 6, 2006
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Procedure: Vitrectomy Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2006
Estimated Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Surgical time
  2. Facility of surgical maneuvers

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced diabetic retinopathy with retinal detachment

Exclusion Criteria:

  • Retinal detachments of more than 6 months
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407108


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

Locations
Mexico
Asociación para Evitar la Ceguera en Mexico, Hospital "Luis Sanchez Bulnes" Recruiting
Mexico City, Mexico DF, Mexico, 04030
Contact: Maria A Martínez-Cstellanos, MD    52 55 10841400 ext 1171    retinamex@yahoo.com   
Principal Investigator: Hugo Quiroz-Mercado, MD         
Sub-Investigator: María A Martinez-Castellanos, MD         
Sub-Investigator: Gerardo García-Aguirre, MD         
Sub-Investigator: Orlando Ustariz-González, 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 México
More Information

ClinicalTrials.gov Identifier: NCT00407108     History of Changes
Other Study ID Numbers: APEC-005
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: December 6, 2006
Last Verified: November 2006

Keywords provided by Asociación para Evitar la Ceguera en México:
vitreoretinal surgery

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases