Trial record 1 of 40 for:    "Central serous chorioretinopathy"
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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:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00803517
First received: November 12, 2008
Last updated: March 11, 2009
Last verified: February 2009
  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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00803517     History of Changes
Other Study ID Numbers: 2008-05-030
Study First Received: November 12, 2008
Results First Received: November 12, 2008
Last Updated: March 11, 2009
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014