Persona of Central Serous Chorioretinopathy

Personality Type Clinical Trial

— CSCR  

Official title:

Persona of Central Serous Chorioretinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819622
• Other study ID #: INV-2014-204
• Status: Completed
• Phase: N/A
• First received: June 14, 2016
• Last updated: June 27, 2016
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Rafic Hariri University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Personality Type

Locations

Country	Name	City	State
Lebanon	Rafic Hariri University Hospital	Beirut	South Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Rafic Hariri University Hospital

Country where clinical trial is conducted

Lebanon, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

Mateo-Montoya A, Mauget-Faÿse 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. Review. — View Citation

Saccà 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	personality type	one interview by the ophthalmologist himself	through study completion, an average of 1 year	No