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Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters (PFC)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT01023698
First received: November 26, 2009
Last updated: December 1, 2009
Last verified: December 2009
History of Changes
  Purpose

Is it possible to do a panretinal photocoagulation for proliferative diabetic retinopathy in a single session using low fluence parameters?


Condition Intervention Phase
Neovascular
 Procedure: laser photocoagulation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Stabilization of proliferative diabetic retinopathy [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: photocoagulation
Laser photocoagulation
 Procedure: laser photocoagulation
Laser photocoagulation

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • untreated Proliferative diabetic retinopathy

Exclusion Criteria:

  • Previous photocoagulation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023698

Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Maria A Martinez-Castellanos, MD Asociacion para Evitar la Ceguera en México
  More Information

No publications provided

Responsible Party: Maria Ana Martínez Castellanos MD, Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT01023698     History of Changes
Other Study ID Numbers: APEC0003
Study First Received: November 26, 2009
Last Updated: December 1, 2009
Health Authority: Mexico: Ministry of Health

Keywords provided by Asociación para Evitar la Ceguera en México:
Diabetic retinopathy
Diabetic macular edema
Panretinal photocoagulation

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

ClinicalTrials.gov processed this record on June 18, 2013