Central Serous ChorioretinopathyNCT00803517
Comparison of Multifocal Electroretinogram Assessment in Chronic Central Serous Chorioretinopathy (CSC) Between Laser Treatment Group and Photodynamic Therapy Group in Chronic Central Serous Chorioretinopathy
An observational study of Central Serous Chorioretinopathy, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to Oct 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- Laser Group: extrafoveal focal leakage on FAG
- 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
- Chronic serous chorioretinopathy (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
Exclusion criteria
- previous PDT or laser treatment history
- evidence of Choriinal neovascularization 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 follow-up Visit
1)baseline 2)1month 3)3months 4)6 months
each visit: multifocal electroretinogram, visual acuity, optical coference timography should be measured.
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- chronic central serous chorioretinopathy, multifocal electroretinogram, central retinal function after treatment in chronic serous chorioretinopathy
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy (PDT) | Not described | |
| Focal laser photocoagulation (focal) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 1 month, 3 months, 6 months
Secondary outcomes (1)
Best Corrected Visual Acuity
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.
Measured: baseline, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Se Woong Kang, MD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803517
- Sponsor's protocol ID
- 2008-05-030
- Status last verified
- Feb 2009
- First submitted
- 12 Nov 2008
- Last updated
- 12 Mar 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Multifocal Electroretinogram Assessment Between Laser Treatment Group and Photodynamic Therapy Group in Chronic Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT00803517
- Acronym / sponsor ID
- 2008-05-030
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- chronic central serous chorioretinopathy, multifocal electroretinogram, central retinal function after treatment in chronic serous chorioretinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 5 Dec 2008
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a comparison of multifocal electroretinogram assessment between the laser treatment group and the photodynamic therapy group in chronic central serous chorioretinopathy.
Detailed description
- Laser Group: extrafoveal focal leakage on FAG
- 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
- Chronic serous chorioretinopathy (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
Exclusion criteria
- previous PDT or laser treatment history
- evidence of Choriinal neovascularization 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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy (PDT) | – | – |
| Focal laser photocoagulation (focal) | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Best Corrected Visual Acuity
Time frame: baseline, 1 month, 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Se Woong Kang, MD study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Serous Chorioretinopathy, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multifocal Electroretinogram Amplitudes (time frame: baseline, 1 month, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2009.