Pain Perception at Laser Treatment

May 19, 2010 updated by: University of Campinas, Brazil

Pain Perception at Laser Treatment of Peripheral Retinal Degenerations With Green and Infrared Wavelengths

The purpose of this study is to compare the pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: To compare the pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths.

Methods: Thirty patients (60 eyes) were enrolled in the study. Each patient had one eye treated with infrared laser (diode, 810nm) and the other eye treated with green laser (frequency-doubled solid state laser, diode-pumped, with 532-nm). The laser treatment was performed following a standardized protocol. Immediately after photocoagulation, the patient was asked to grading pain perception according an 11-point (i.e. 0-10) numerical rating scale (NRS) 2,3, accompanied by the instructions "Please rate your pain by indicating the number that best describes it". This NRS is represented as a straight line (10 cm in length). The numbers between 0 and 10 are spaced at regular intervals along the line, at either end of the line are two poles that are defined as the extreme limits of the response to be measure, with '0' meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine'.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • horseshoe tears and dialyses, besides operculated holes and lattice degeneration in symptomatic patients (photopsias) or with history of retinal disease

Exclusion Criteria:

  • severe liver disease, pregnancy, patients on regular analgesics, previous laser photocoagulation, and age less than 18 years old.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Although the treatment of peripheral retinal degenerations with infrared laser to be well tolerated by the majority of the patients, it is more painful than with green wavelength.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (Estimate)

December 17, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2010

Last Update Submitted That Met QC Criteria

May 19, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Lira-001

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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