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Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Retinal laser photocoagulation
Sponsored by
Asociación para Evitar la Ceguera en México
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Proliferative diabetic retinopathy, Laser photocoagulation, Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asociacion para Evitar la Ceguera en Mexico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reduced Fluence Parameters

Traditional parameters

Arm Description

Eyes receiving retinal photocoagulation with reduced fluence parameters (time 20-50 msec, power 400-700 mW)

Eyes receiving retinal photocoagulation with traditional parameters (time 100-200 msec, power 200-400 mW)

Outcomes

Primary Outcome Measures

Pain (NRS-11 scale)

Secondary Outcome Measures

Full Information

First Posted
December 3, 2008
Last Updated
December 3, 2008
Sponsor
Asociación para Evitar la Ceguera en México
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1. Study Identification

Unique Protocol Identification Number
NCT00802269
Brief Title
Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.
Official Title
Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Asociación para Evitar la Ceguera en México

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The used of reduced fluence parameters for panretinal photocoagulation decreases pain as perceived by the patient, compared to traditional parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
Proliferative diabetic retinopathy, Laser photocoagulation, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduced Fluence Parameters
Arm Type
Experimental
Arm Description
Eyes receiving retinal photocoagulation with reduced fluence parameters (time 20-50 msec, power 400-700 mW)
Arm Title
Traditional parameters
Arm Type
Active Comparator
Arm Description
Eyes receiving retinal photocoagulation with traditional parameters (time 100-200 msec, power 200-400 mW)
Intervention Type
Procedure
Intervention Name(s)
Retinal laser photocoagulation
Other Intervention Name(s)
Alcon Eyelite 532 (doubled frequency Nd:Yag)
Intervention Description
Retinal laser photocoagulation using a 532 nm laser
Primary Outcome Measure Information:
Title
Pain (NRS-11 scale)
Time Frame
Immediately post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Alvarez-Verduzco, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociacion para Evitar la Ceguera en Mexico
City
Mexico City
State/Province
DF
ZIP/Postal Code
04030
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.

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