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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014