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Persona of Central Serous Chorioretinopathy (CSCR)

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ClinicalTrials.gov Identifier: NCT02819622
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmad Mansour, MD, Clinical Professor, AUB, Rafic Hariri University Hospital

Brief Summary:

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.


Condition or disease
Personality Type

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.

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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Persona of Central Serous Chorioretinopathy
Study Start Date : January 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. personality type [ Time Frame: through study completion, an average of 1 year ]
    one interview by the ophthalmologist himself



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with central serous retinopathy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819622


Locations
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Lebanon
Rafic Hariri University Hospital
Beirut, South Beirut, Lebanon, 1136044
Sponsors and Collaborators
Rafic Hariri University Hospital
Investigators
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Principal Investigator: ahmad mansour, md RHUH
Publications:
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Responsible Party: Ahmad Mansour, MD, Clinical Professor, AUB, Chair, Department of Opthalmology, Rafic Hariri Hospital, Rafic Hariri University Hospital
ClinicalTrials.gov Identifier: NCT02819622    
Other Study ID Numbers: INV-2014-204
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publication and excel sheet
Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases