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Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01327170
First Posted: April 1, 2011
Last Update Posted: April 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  Purpose
The aim of this study was to evaluate safety and therapeutic response to micropulse diode 810nm laser treatment in patients with chronic central serous chorioretinopathy.

Condition Intervention
Central Serous Chorioretinopathy Procedure: Subthreshold diode micropulse laser

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy: Evaluation by Fundus Autofluorescence and Spectral Domain Optical Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: 6 months ]
    Best corrected visual acuity measured by ETDRS chart at baseline, 1, 3, 6, 9 and 12 months


Secondary Outcome Measures:
  • Macular subretinal fluid [ Time Frame: 6 months ]
    Central macular thickness measured by spectral-domain optical coherence tomography at baseline, 1, 3, 6, 9 and 12 months

  • Leakage at fluorescein angiogram [ Time Frame: 6 months ]
    Leakage at fluorescein angiogram evaluated at baseline, 3, 6, 9 and 12 months


Enrollment: 15
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subthreshold diode micropulse laser
Subthreshold diode micropulse laser in patients with chronic central serous chorioretinopathy
Procedure: Subthreshold diode micropulse laser
Sham Comparator: Sham
Sham group simulating the laser treatment
Procedure: Subthreshold diode micropulse laser

Detailed Description:
Most of the cases of central serous chorioretinopathy (CSC) recur spontaneously within three months of disease. After 3 months without resolution of acute CSC or in chronic CSC, continuous wave laser photocoagulation or photodynamic therapy should be considered. Direct threshold continuous photocoagulation treatment can shorten the duration of the serous detachment, but it is not appropriate for juxtafoveal or subfoveal leakage point.Subvisible photocoagulation potentially localizes and decreases chorioretinal thermic burn. Subthreshold diode micropulse (SDM) laser using a 810nm diode laser may spare the damage to the neural retina by raising the temperature of the RPE to just below the protein-denaturation threshold so that the thermal wave that reaches the neural retina is insufficient to cause neither damage nor clinically visible end-point. This therapeutic laser modality offers the possibility to minimize the iatrogenic retinal lesion.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic active central serous chorioretinopathy lasting more than 6 months
  • Leakage at fluorescein angiogram

Exclusion Criteria:

  • Opacities of the clear refractive media of the eye
  • Any intraocular surgery within the 6 months prior to study entry
  • Prior vitrectomy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327170


Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Fernanda P Magalhaes, MD Federal University of São Paulo
  More Information

Responsible Party: Fernanda Pedreira Magalhães, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01327170     History of Changes
Other Study ID Numbers: SDMCCSC-FM
First Submitted: March 29, 2011
First Posted: April 1, 2011
Last Update Posted: April 1, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases