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Comparison of Multifocal Electroretinogram Assessment in Chronic Central Serous Chorioretinopathy (CSC) Between Laser Treatment Group and Photodynamic Therapy Group in Chronic Central Serous Chorioretinopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00803517
First Posted: December 5, 2008
Last Update Posted: July 29, 2009
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:
Samsung Medical Center
  Purpose
This study is a comparison of multifocal electroretinogram assessment between the laser treatment group and the photodynamic therapy group in chronic central serous chorioretinopathy.

Condition
Central Serous Chorioretinopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Multifocal Electroretinogram Assessment Between Laser Treatment Group and Photodynamic Therapy Group in Chronic Central Serous Chorioretinopathy

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Multifocal Electroretinogram Amplitudes [ Time Frame: baseline, 1 month, 3 months, 6 months ]

Secondary Outcome Measures:
  • Best Corrected Visual Acuity [ Time Frame: baseline, 1 month, 3 months, 6 months ]

Enrollment: 24
Study Start Date: March 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Photodynamic therapy (PDT)
Focal laser photocoagulation (focal)

Detailed Description:
  1. Laser Group: extrafoveal focal leakage on FAG
  2. PDT Group: no definite focal leak on FAG subfoveal or juxtafoveal focal leakage on FAG, or serous retinal pigmentary epithelial detachment involving foveal center

Inclusion criteria

  1. Chronic serous chorioretinopathy (over 3 months) when subretinal fluid persisted in the subfoveal region demonstrated by clinical examination and OCT
  2. Ability to maintain steady fixation for mfERG
  3. Presence of abnormal dilated choroidal vasculature in ICGA
  4. Symptom duration over 3 months

Exclusion criteria

  1. previous PDT or laser treatment history
  2. evidence of Choriinal neovascularization in FAG
  3. other chorioretinal disorders that can cause macular exudation such as age-related macular degeneration, pathologic myopia, angioid streaks, trauma, inflammatory diseases, retinal vasculopathies, and hereditary dystrophies

follow-up Visit

1)baseline 2)1month 3)3months 4)6 months

each visit: multifocal electroretinogram, visual acuity, optical coference timography should be measured.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Laser Group: extrafoveal focal leakage on FAG
  2. photodynamic therapy Group: no definite focal leak on FAG subfoveal or juxtafoveal focal leakage on FAG, or s-RPED involving foveal center
Criteria

Inclusion Criteria:

  1. CSC (over 3 months) when subretinal fluid persisted in the subfoveal region demonstrated by clinical examination and OCT
  2. Ability to maintain steady fixation for mfERG
  3. Presence of abnormal dilated choroidal vasculature in ICGA
  4. Symptom duration over 3 months

Exclusion Criteria:

  1. Previous PDT or laser treatment history
  2. Evidence of CNV in FAG
  3. Other chorioretinal disorders that can cause macular exudation such as age-related macular degeneration, pathologic myopia, angioid streaks, trauma, inflammatory diseases, retinal vasculopathies, and hereditary dystrophies
  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): NCT00803517


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Chair: Se Woong Kang, MD Samsung Medical Center
  More Information

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00803517     History of Changes
Other Study ID Numbers: 2008-05-030
First Submitted: November 12, 2008
First Posted: December 5, 2008
Results First Submitted: November 12, 2008
Results First Posted: December 5, 2008
Last Update Posted: July 29, 2009
Last Verified: February 2009

Keywords provided by Samsung Medical Center:
chronic central serous chorioretinopathy
multifocal electroretinogram
central retinal function after treatment in chronic serous chorioretinopathy

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