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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

December 16, 2009
May 19, 2010
January 2009
December 2009   (final data collection date for primary 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. [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01033968 on ClinicalTrials.gov Archive Site
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Pain Perception at Laser Treatment
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.

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'.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Laser Therapy, Low-Level
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
Not Provided
Lira RP, Nascimento MA, Arieta CE, de Carvalho KM, Silva VB. Pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths. Am J Ophthalmol. 2010 Nov;150(5):726-730.e1. Epub 2010 Aug 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01033968
Lira-001
Yes
Rodrigo Pessoa Cavalcanti Lira, UNICAMP
University of Campinas, Brazil
Not Provided
Not Provided
University of Campinas, Brazil
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP