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Pain Perception at Laser Treatment

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ClinicalTrials.gov Identifier: NCT01033968
Recruitment Status : Completed
First Posted : December 17, 2009
Last Update Posted : May 20, 2010
Sponsor:
Information provided by:
University of Campinas, Brazil

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

Condition or disease Intervention/treatment Phase
Laser Therapy, Low-Level Procedure: retina photocoagulation Phase 4

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pain Perception at Laser Treatment of Peripheral Retinal Degenerations With Green and Infrared Wavelengths
Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2010

Intervention Details:
    Procedure: retina photocoagulation
    Each patient had one eye treated with infrared laser (diode, 810nm wavelength) and the other eye treated with green laser (frequency-doubled solid state laser, diode-pumped, with 532-nm wavelength


Primary Outcome Measures :
  1. 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.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rodrigo Pessoa Cavalcanti Lira, UNICAMP
ClinicalTrials.gov Identifier: NCT01033968     History of Changes
Other Study ID Numbers: Lira-001
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: May 20, 2010
Last Verified: May 2010

Keywords provided by University of Campinas, Brazil:
lasers
pain measurement
photocoagulation
retina