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Pain Perception at Laser Treatment

This study has been completed.
Sponsor:
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01033968
First received: December 16, 2009
Last updated: May 19, 2010
Last verified: May 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Laser Therapy, Low-Level
 Procedure: retina photocoagulation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pain Perception at Laser Treatment of Peripheral Retinal Degenerations With Green and Infrared Wavelengths

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2009
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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
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'.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by University of Campinas, Brazil

Additional 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
Study First Received: December 16, 2009
Last Updated: May 19, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013