Personality TypeCSCRNCT02819622
Persona of Central Serous Chorioretinopathy
An observational study of Personality Type, run by Rafic Hariri University Hospital at 1 site in Lebanon.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Personality Type
- How many people
- 83 participants
- Where
- 1 siteLebanon
- Study dates
- Jan 2015to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with central serous retinopathy
Who may be able to join
- clinical evidence by fluorescein angiography and OCT of CSCR disease
- willingness to undergo long interview
- ability to sign an informed consent
Who cannot join
- severe systemic hypertension
- eclampsia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Personality Type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | control (no disease) | |
| central serous retinopathy group | Central serous retinopathy (with CSCR disease) by exam and OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
personality type
one interview by the ophthalmologist himself
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Personality TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rafic Hariri University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mansour, MD, Clinical Professor, AUB, Rafic Hariri University Hospital
- Investigators
- ahmad mansour, md, Principal investigator, RHUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819622
- Sponsor's protocol ID
- INV-2014-204
- Acronym
- CSCR
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: publication and excel sheet
Publications
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.
PubMed 26710181Daruich 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.
PubMed 26026923Sacca 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.
PubMed 25526440Mateo-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.
PubMed 25133035
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persona of Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT02819622
- Acronym / sponsor ID
- CSCR / INV-2014-204
- Conditions
- Personality Type
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Rafic Hariri University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –control (no disease) |
| central serous retinopathy group | – | –Central serous retinopathy (with CSCR disease) by exam and OCT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with central serous retinopathy
Key inclusion criteria (3 listed)
- clinical evidence by fluorescein angiography and OCT of CSCR disease
- willingness to undergo long interview
- ability to sign an informed consent
Key exclusion criteria (2 listed)
- severe systemic hypertension
- eclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
personality type
Time frame: through study completion, an average of 1 year
one interview by the ophthalmologist himself
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Background: PubMed 26710181Liu 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.
- Background: PubMed 26026923Daruich 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.
- Background: PubMed 25526440Sacca 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.
- Background: PubMed 25133035Mateo-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.
- Individual participant dataSharing planned: Yes. publication and excel sheet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmad mansour, md principal investigator
RHUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Personality Type, run by Rafic Hariri University Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
personality type (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02819622, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.