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

March 11, 2009 updated by: Samsung Medical Center

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

This study is a comparison of multifocal electroretinogram assessment between the laser treatment group and the photodynamic therapy group in chronic central serous chorioretinopathy.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Photodynamic therapy (PDT)
Focal laser photocoagulation (focal)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multifocal Electroretinogram Amplitudes
Time Frame: baseline, 1 month, 3 months, 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity
Time Frame: baseline, 1 month, 3 months, 6 months
Best-corrected visual acuities were obtained with Snellen charts. Snellen's visual acuity was converted logarithm of the minimum angle of resolution (logMAR) for statistical analysis.
baseline, 1 month, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Study Chair: Se Woong Kang, MD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

December 3, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 11, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-05-030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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