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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
History of Changes
Results First Received: November 12, 2008  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: Central Serous Chorioretinopathy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Photodynamic Therapy No text entered.
Focal Laser Photocoagulation No text entered.

Participant Flow:   Overall Study
    Photodynamic Therapy     Focal Laser Photocoagulation  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Photodynamic Therapy No text entered.
Focal Laser Photocoagulation No text entered.
Total Total of all reporting groups

Baseline Measures
    Photodynamic Therapy     Focal Laser Photocoagulation     Total  
Number of Participants  
[units: participants]
 		  12     12     24  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     12     12     24  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  42.35  ± 6.89     44.26  ± 5.89     43.31  ± 7.89  
Gender  
[units: participants]
 		     
Female     1     1     2  
Male     11     11     22  
Region of Enrollment  
[units: participants]
 		     
Korea, Republic of     12     12     24  



  Outcome Measures
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1.  Primary:   Multifocal Electroretinogram Amplitudes   [ Time Frame: baseline, 1 month, 3 months, 6 months ]
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2.  Secondary:   Best Corrected Visual Acuity   [ Time Frame: baseline, 1 month, 3 months, 6 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Jiwon Lim
Organization: Samsung Medical Center
phone: 82-10-9933-5596
e-mail: samnyasa@naver.com


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