Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation

This study has been completed.
Sponsor:
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01068379
First received: February 11, 2010
Last updated: May 24, 2010
Last verified: May 2010

February 11, 2010
May 24, 2010
July 2006
January 2009   (final data collection date for primary outcome measure)
The primary outcome was one week reattachment rate [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01068379 on ClinicalTrials.gov Archive Site
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Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation
Randomized Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation for Retinopexy in Scleral Buckle Surgery

The purpose of this randomized clinical trial was to compare reattachment rates among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.

The purpose of this randomized clinical trial was to compare reattachment rates, visual acuity results and epiretinal membrane formation among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Rhegmatogenous Retinal Detachment
  • Procedure: criopexy
    he cryopexy was performed by placement of a normal spherical probe under the bucklings, around the break. The number of cryo applications was limited in number of 3. Freezing was stopped at the beginning of retinal whitening.
  • Procedure: laser
    Laser-retinopexy was performed after proper positioning the patients; laser energy was delivered by depressing a foot pedal. Short burn duration (0.1 seconds) and low (300-miliWatts) power settings were used initially, and both the burn duration and power were gradually increased as determined by observation.
  • Experimental: Cryopexy
    the cryopexy was performed by placement of a normal spherical probe under the bucklings, around the break. The number of cryo applications was limited in number of 3. Freezing was stopped at the beginning of retinal whitening.
    Intervention: Procedure: criopexy
  • Experimental: laser photocoagulation 4 weeks after
    Laser-retinopexy was performed after proper positioning the patients; laser energy was delivered by depressing a foot pedal. Short burn duration (0.1 seconds) and low (300-miliWatts) power settings were used initially, and both the burn duration and power were gradually increased as determined by observation.
    Intervention: Procedure: laser
Lira RP, Takasaka I, Arieta CE, Nascimento MA, Caldato R, Panetta H. Cryotherapy vs laser photocoagulation in scleral buckle surgery: A randomized clinical trial. Arch Ophthalmol. 2010 Dec;128(12):1519-22. doi: 10.1001/archophthalmol.2010.271.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
Not Provided
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary rhegmatogenous retinal detachment with a single peripherical retinal break. All patients were phakic, under eighteen years old, with partial posterior vitreous detachment, visual loss or symptoms (floaters and photopsia) less than 30 days

Exclusion Criteria:

  • No patient had a retinal break greater than 30 degrees, or retinal detachment larger than two quadrants, history of uveitis or infectious retinopathy, presence of Proliferative vitreoretinopathy (B or C), macular disease, glaucoma, hemoglobinopathy, diabetic retinopathy, and history of trauma or previous vitreoretinal surgery.
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01068379
cryo laser
Yes
Rodrigo Pessoa Cavalcante 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