Central Serous ChorioretinopathyNCT01378130
Central Serous Chorioretinopathy: Etiology, Course and Prognosis
An observational study of Central Serous Chorioretinopathy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Pathogenesis of central serous chorioretinopathy is not entirely understood yet, therefore further investigations are needed. During this study patients with an acute episode of central serous chorioretinopathy are observed with established ophthalmologic methods (multimodal imagine) every 6 weeks until subretinal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Serous Chorioretinopathy
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2011to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an acute episode of central serous chorioretinopathy are recruited from the Department of Ophthalmology at the Medical University of Vienna.
Who may be able to join
- Signed informed consent form
- Age over 18 years
- acute episode of Central Serous Chorioretinopathy
- Symptoms for less than two weeks
- no treatment on study eye
Who cannot join
- bad compliance
- protected patient group (pregnant women)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Serous Chorioretinopathy: An Observational Study About Etiology, Course and Prognosis
Pathogenesis of central serous chorioretinopathy is not entirely understood yet, therefore further investigations are needed. During this study patients with an acute episode of central serous chorioretinopathy are observed with established ophthalmologic methods (multimodal imagine) every 6 weeks until subretinal fluid is reabsorbed to gain further insides in etiology, course and prognosis of this disease.
Read the detailed description
Patients with central serous chorioretinopathy are recruited from the Department of Ophthalmology at the Medical University of Vienna. All patients undergo ETDRS visual acuity measurement, Pelli-Robson contrast examination, Amsler-Grid testing, questionnaire testing, ophthalmologic examination, SD-OCT and polarization-sensitive OCT, fundus autofluorescence, fluorescein angiography, indocyanine-green angiography, fundus photo and microperimetry. Patients are re-examined after an interval of 6 weeks until subretinal fluid is entirely reabsorbed to gain further insides in etiology, course and prognosis of this disease.
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- CCS, CSC, Subretinal Fluid, multimodal imaging
- Medical subject headings
- Central Serous Chorioretinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome
OCT, Visus
Measured: 2 years
Secondary outcomes (1)
Subclinical Data
FA findings, retinal sensitivity in Microperimetry, contrast sensitivity, Amsler Grid Test
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Sacu, Medical University of Vienna
- Investigators
- Stefan Sacu, Ass.Prof.Dr., Principal investigator, Department of Ophthalmology, Medical University of Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378130
- Sponsor's protocol ID
- EK 180/2011
- Status last verified
- Apr 2013
- First submitted
- 20 Jun 2011
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Serous Chorioretinopathy: An Observational Study About Etiology, Course and Prognosis
- ClinicalTrials.gov ID
- NCT01378130
- Acronym / sponsor ID
- EK 180/2011
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- CCS, CSC, Subretinal Fluid, multimodal imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pathogenesis of central serous chorioretinopathy is not entirely understood yet, therefore further investigations are needed. During this study patients with an acute episode of central serous chorioretinopathy are observed with established ophthalmologic methods (multimodal imagine) every 6 weeks until subretinal fluid is reabsorbed to gain further insides in etiology, course and prognosis of this disease.
Detailed description
Patients with central serous chorioretinopathy are recruited from the Department of Ophthalmology at the Medical University of Vienna. All patients undergo ETDRS visual acuity measurement, Pelli-Robson contrast examination, Amsler-Grid testing, questionnaire testing, ophthalmologic examination, SD-OCT and polarization-sensitive OCT, fundus autofluorescence, fluorescein angiography, indocyanine-green angiography, fundus photo and microperimetry. Patients are re-examined after an interval of 6 weeks until subretinal fluid is entirely reabsorbed to gain further insides in etiology, course and prognosis of this disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an acute episode of central serous chorioretinopathy are recruited from the Department of Ophthalmology at the Medical University of Vienna.
Key inclusion criteria (5 listed)
- Signed informed consent form
- Age over 18 years
- acute episode of Central Serous Chorioretinopathy
- Symptoms for less than two weeks
- no treatment on study eye
Key exclusion criteria (2 listed)
- bad compliance
- protected patient group (pregnant women)
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
Clinical Outcome
Time frame: 2 years
OCT, Visus
1 secondary outcome
Subclinical Data
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
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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.
Stefan Sacu, Ass.Prof.Dr. principal investigator
Department of Ophthalmology, Medical University of Vienna, Austria
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 Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 2 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 26 Apr 2013. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Outcome (time frame: 2 years). 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 26 Apr 2013.