NCT02819622

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

June 14, 2016

Last Update Submit

June 27, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • personality type

    one interview by the ophthalmologist himself

    through study completion, an average of 1 year

Study Arms (2)

Control group

control (no disease)

central serous retinopathy group

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

Eligibility Criteria

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

patients with central serous retinopathy

You may qualify if:

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

You may not qualify if:

  • severe systemic hypertension
  • eclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rafic Hariri University Hospital

Beirut, South Beirut, 1136044, Lebanon

Location

Related Publications (4)

  • 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.

    PMID: 26710181BACKGROUND
  • 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.

    PMID: 26026923BACKGROUND
  • 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.

    PMID: 25526440BACKGROUND
  • 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.

    PMID: 25133035BACKGROUND

Study Officials

  • ahmad mansour, md

    RHUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Opthalmology, Rafic Hariri Hospital

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 30, 2016

Study Start

January 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

June 30, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

publication and excel sheet

Locations