NCT01610804

Brief Summary

The purpose of this study is to determine changes in choroidal thickness in patients with Central Serous Chorioretinopathy (CSCR) during the first 3 months after initial diagnosis via Enhanced-Depth-Imaging-Spectral-Domain-Optical-Coherence-Tomography (EDI-OCT). Study hypothesis: Since exudative changes in the choroid seem to constitute the primary pathology of CSCR, changes in choroidal thickness compared to healthy eyes should be present and be visible using EDI-OCT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
Last Updated

June 4, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

May 31, 2012

Last Update Submit

June 1, 2012

Conditions

Choroidal Thickness

Study Arms (2)

CSCR-Patients

Patients suffering from Central Serous Chorioretinopathy

Healthy Subjects

Healthy subjects with (assumed) normal choroidal thickness

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with reduction of vision due to Central Serous Chorioretinopathy

You may qualify if:

  • Patients with initial diagnosis of CSCR and no treatment so far

You may not qualify if:

  • Therapy (drugs/laser) due to CSCR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Related Publications (2)

  • Imamura Y, Fujiwara T, Margolis R, Spaide RF. Enhanced depth imaging optical coherence tomography of the choroid in central serous chorioretinopathy. Retina. 2009 Nov-Dec;29(10):1469-73. doi: 10.1097/IAE.0b013e3181be0a83.

    PMID: 19898183BACKGROUND

  • Margolis R, Spaide RF. A pilot study of enhanced depth imaging optical coherence tomography of the choroid in normal eyes. Am J Ophthalmol. 2009 May;147(5):811-5. doi: 10.1016/j.ajo.2008.12.008. Epub 2009 Feb 20.

    PMID: 19232559BACKGROUND

Study Officials

  • Maria A Gamulescu, PD Dr. med.

    University Hospital Regensburg

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 4, 2012

Study Start

April 1, 2011

Primary Completion

November 1, 2011

Study Completion

May 1, 2012

Last Updated

June 4, 2012

Record last verified: 2012-05

Locations

DE(1)