- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00802269
Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.
December 3, 2008 updated by: Asociación para Evitar la Ceguera en México
The used of reduced fluence parameters for panretinal photocoagulation decreases pain as perceived by the patient, compared to traditional parameters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DF
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Mexico City, DF, Mexico, 04030
- Asociación Para Evitar la Ceguera en México
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients 18 years or older, that signed informed consent
- Proliferative diabetic retinopathy with indication for panretinal photocoagulation
Exclusion Criteria:
- Previous retinal photocoagulation
- Previous ocular surgical procedures
- Ocular media opacities
- History of trigeminal neuralgia
- Chronic ocular pain
- Depression under conductual or medical treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reduced Fluence Parameters
Eyes receiving retinal photocoagulation with reduced fluence parameters (time 20-50 msec, power 400-700 mW)
|
Retinal laser photocoagulation using a 532 nm laser
Other Names:
|
Active Comparator: Traditional parameters
Eyes receiving retinal photocoagulation with traditional parameters (time 100-200 msec, power 200-400 mW)
|
Retinal laser photocoagulation using a 532 nm laser
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain (NRS-11 scale)
Time Frame: Immediately post-treatment
|
Immediately post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Oscar Alvarez-Verduzco, MD, Asociación Para Evitar la Ceguera en México
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
December 3, 2008
First Submitted That Met QC Criteria
December 3, 2008
First Posted (Estimate)
December 4, 2008
Study Record Updates
Last Update Posted (Estimate)
December 4, 2008
Last Update Submitted That Met QC Criteria
December 3, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APEC-032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on Retinal laser photocoagulation
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United Christian HospitalThe University of Hong KongCompletedDiabetic Retinopathy | Lasers | Treatment Outcome
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Wills EyeMid Atlantic RetinaCompletedProliferative Diabetic Retinopathy - High RiskUnited States
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Moorfields Eye Hospital NHS Foundation TrustInsulin Dependant Diabetes TrustCompletedProliferative Diabetic RetinopathyUnited Kingdom
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David M. Brown, M.D.Genentech, Inc.CompletedDiabetic Macular EdemaUnited States
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