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

Central Serous Chorioretinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803517
• Other study ID #: 2008-05-030
• Status: Completed
• Phase: N/A
• First received: November 12, 2008
• Last updated: March 11, 2009
• Start date: March 2008
• Est. completion date: October 2008

Study information

• Verified date: February 2009
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multifocal Electroretinogram Amplitudes		baseline, 1 month, 3 months, 6 months	Yes
Secondary	Best Corrected Visual Acuity		baseline, 1 month, 3 months, 6 months	Yes