Comparison of Multifocal Electroretinogram Assessment in Chronic Central Serous Chorioretinopathy (CSC) Between Laser Treatment Group and Photodynamic Therapy Group in Chronic Central Serous Chorioretinopathy
1 other identifier
observational
24
1 country
1
Brief Summary
This study is a comparison of multifocal electroretinogram assessment between the laser treatment group and the photodynamic therapy group in chronic central serous chorioretinopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 12, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedResults Posted
Study results publicly available
December 5, 2008
CompletedMarch 12, 2009
February 1, 2009
7 months
November 12, 2008
November 12, 2008
March 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Multifocal Electroretinogram Amplitudes
Amplitude at first annular ring at multifocal electroretinogram RETIscan (Roland Consult, Wiesbaden, Germany) is used for multifocal retinogram. The recording protocol was chosen according to the International Society for Clinical Electro-physiology of Vision (ISCEV) guidelines.
baseline, 1 month, 3 months, 6 months
Secondary Outcomes (1)
Best Corrected Visual Acuity
baseline, 1 month, 3 months, 6 months
Study Arms (2)
Photodynamic therapy (PDT)
Focal laser photocoagulation (focal)
Eligibility Criteria
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
You may qualify if:
- CSC (over 3 months) when subretinal fluid persisted in the subfoveal region demonstrated by clinical examination and OCT
- Ability to maintain steady fixation for mfERG
- Presence of abnormal dilated choroidal vasculature in ICGA
- Symptom duration over 3 months
You may not qualify if:
- Previous PDT or laser treatment history
- Evidence of CNV in FAG
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Seoul, 135-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jiwon Lim
- Organization
- Samsung Medical Center
Study Officials
- STUDY CHAIR
Se Woong Kang, MD
Samsung Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 12, 2008
First Posted
December 5, 2008
Study Start
March 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
March 12, 2009
Results First Posted
December 5, 2008
Record last verified: 2009-02