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Central Serous Chorioretinopathy: Etiology, Course and Prognosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01378130
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):
Stefan Sacu, Medical University of Vienna

Tracking Information
First Submitted Date June 20, 2011
First Posted Date June 22, 2011
Last Update Posted Date April 26, 2013
Study Start Date April 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2013)
Clinical Outcome [ Time Frame: 2 years ]
OCT, Visus
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: April 25, 2013)
Subclinical Data [ Time Frame: 2 years ]
FA findings, retinal sensitivity in Microperimetry, contrast sensitivity, Amsler Grid Test
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Central Serous Chorioretinopathy: Etiology, Course and Prognosis
Official Title Central Serous Chorioretinopathy: An Observational Study About Etiology, Course and Prognosis
Brief 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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with an acute episode of central serous chorioretinopathy are recruited from the Department of Ophthalmology at the Medical University of Vienna.
Condition Central Serous Chorioretinopathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 21, 2011)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • bad compliance
  • protected patient group (pregnant women)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT01378130
Other Study ID Numbers EK 180/2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stefan Sacu, Medical University of Vienna
Study Sponsor Medical University of Vienna
Collaborators Not Provided
Investigators
Principal Investigator: Stefan Sacu, Ass.Prof.Dr. Department of Ophthalmology, Medical University of Vienna, Austria
PRS Account Medical University of Vienna
Verification Date April 2013