Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.

May 29, 2024 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

Terminated

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

  • Mexico
    • DF
      • Mexico City, DF, Mexico, 04030
        • Asociación Para Evitar la Ceguera en México

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

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)
Procedure: Retinal laser photocoagulation
Retinal laser photocoagulation using a 532 nm laser
Other Names:
  • Alcon Eyelite 532 (doubled frequency Nd:Yag)
Active Comparator: Traditional parameters
Eyes receiving retinal photocoagulation with traditional parameters (time 100-200 msec, power 200-400 mW)
Procedure: Retinal laser photocoagulation
Retinal laser photocoagulation using a 532 nm laser
Other Names:
  • Alcon Eyelite 532 (doubled frequency Nd:Yag)

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.

Sponsor

Asociación para Evitar la Ceguera en México

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 (Estimated)

December 4, 2008

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

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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