Persona of Central Serous Chorioretinopathy (CSCR)

June 27, 2016 updated by: Ahmad Mansour, MD, Clinical Professor, AUB, Rafic Hariri University Hospital

Purpose: Central serous retinopathy (CSCR) is characterized by macular detachment due to thickened choroid mostly affecting young men under perceived stress. While most previous studies in CSCR have been retrospective and have focused on a single facet of the patient's personality, the investigators conducted a prospective intercontinental controlled study to analyze the multifaceted personality profile in CSCR.

Design: Prospective interview. Participants and Controls: Subjects with CSCR consented to participate in a questionnaire. Controls not having retinal disease were recruited from the same clinic.

Main Outcome Measures: The main parameters registered were presence of stress, daily number of cups caffeine intake, personality traits (Type A; obsessive-compulsive; aggressive).

Methods: The interview consisted of a 60-item questionnaire. Recruitment of participants was from January 2015 to February 2016. Controls were matched for age, gender and race. Statistical analyses were done using univariate and multivariate analysis.

Study Overview

Status

Completed

Conditions

Detailed Description

Central serous chorioretinopathy (CSCR) characterized by serous macular detachment is the fourth most common retinal disease after age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. In a population-based retrospective cohort and case control study in Olmsted county, Minnesota, USA, Kitzmann et al4 reported a mean age-adjusted incidence of 9.9 (95% confidence interval [CI] 7.4-12.4) per 100, 000 in men, and 1.7 (95% CI 0.7-2.7) in women. The mean age of onset of CSCR appears between 41 and 45 years5. The disease affects various racial groups5-8 and occasionally can be familial9. The pathogenesis remains poorly understood and currently the exudation is thought to result from hyper-permeable choroid secondary to venous stasis, ischemia, or inflammation2. Because of lack of proper animal models and lack of definite cure, clinical research has focused on risk factors such as stress, corticosteroid intake, and type A personality. Different hospital-based studies yielded different risk factors. Epidemiologic studies failed to ascertain many of these risk factors. Due to different methodology (retrospective vs. prospective case-control studies; selection of controls; questionnaire vs. interview by physician assistant vs. interview by physician) and focus on single risk factors in the literature, the investigators designed a study that targets a vast number of known or potential risk factors in various collaborative centers and compare it to results reported in the literature.

Study Type

Observational

Enrollment (Actual)

83

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

  • Lebanon
    • South Beirut
      • Beirut, South Beirut, Lebanon, 1136044
        • Rafic Hariri University Hospital

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with central serous retinopathy

Description

Inclusion Criteria:

  • clinical evidence by fluorescein angiography and OCT of CSCR disease
  • willingness to undergo long interview
  • ability to sign an informed consent

Exclusion Criteria:

  • severe systemic hypertension
  • eclampsia

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

Cohorts and Interventions

Group / Cohort
Control group
control (no disease)
central serous retinopathy group
Central serous retinopathy (with CSCR disease) by exam and OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
personality type
Time Frame: through study completion, an average of 1 year
one interview by the ophthalmologist himself
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Rafic Hariri University Hospital

Investigators

  • Principal Investigator: ahmad mansour, md, RHUH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INV-2014-204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

publication and excel sheet

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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