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Persona of Central Serous Chorioretinopathy

NCT ID: NCT02819622

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Personality Type

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

control (no disease)

No interventions assigned to this group

central serous retinopathy group

Central serous retinopathy (with CSCR disease) by exam and OCT

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rafic Hariri University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Mansour, MD, Clinical Professor, AUB

Chair, Department of Opthalmology, Rafic Hariri Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmad mansour, md

Role: PRINCIPAL_INVESTIGATOR

RHUH

Locations

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Rafic Hariri University Hospital

Beirut, South Beirut, Lebanon

Site Status

Countries

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Lebanon

References

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Liu B, Deng T, Zhang J. RISK FACTORS FOR CENTRAL SEROUS CHORIORETINOPATHY: A Systematic Review and Meta-Analysis. Retina. 2016 Jan;36(1):9-19. doi: 10.1097/IAE.0000000000000837.

Reference Type BACKGROUND
PMID: 26710181 (View on PubMed)

Daruich A, Matet A, Dirani A, Bousquet E, Zhao M, Farman N, Jaisser F, Behar-Cohen F. Central serous chorioretinopathy: Recent findings and new physiopathology hypothesis. Prog Retin Eye Res. 2015 Sep;48:82-118. doi: 10.1016/j.preteyeres.2015.05.003. Epub 2015 May 27.

Reference Type BACKGROUND
PMID: 26026923 (View on PubMed)

Sacca SC, Vagge A, Pulliero A, Izzotti A. Helicobacter pylori infection and eye diseases: a systematic review. Medicine (Baltimore). 2014 Dec;93(28):e216. doi: 10.1097/MD.0000000000000216.

Reference Type BACKGROUND
PMID: 25526440 (View on PubMed)

Mateo-Montoya A, Mauget-Fayse M. Helicobacter pylori as a risk factor for central serous chorioretinopathy: Literature review. World J Gastrointest Pathophysiol. 2014 Aug 15;5(3):355-8. doi: 10.4291/wjgp.v5.i3.355.

Reference Type BACKGROUND
PMID: 25133035 (View on PubMed)

Other Identifiers

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INV-2014-204

Identifier Type: -

Identifier Source: org_study_id