UveitisNCT01025986
Uveitis in Relation to Perceived Stress: A Prospective Study
An observational study of Uveitis, run by The New York Eye & Ear Infirmary at 1 site in United States.
Trial summary
The purpose of this study is to conduct a prospective analysis to determine the relationship between disease activity of noninfectious uveitis and stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting at the New York Eye and Ear Infirmary diagnosed with uveitis
Who may be able to join
- At least 18 years of age with a diagnosis of non-infectious uveitis
- Able to self-administer the Perceived Stress Scale (PSS) - 10
Who cannot join
- Diagnosis of infectious uveitis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The New York Eye and Ear Infirmary
New York, New York, 10003
Katy Tai, CCRC, ktai@nyee.edu
C. Michael Samson, MD
About this study
The purpose of this study is to conduct a prospective analysis to determine the relationship between disease activity of noninfectious uveitis and stress.
Read the detailed description
Patients presenting at The New York Eye and Ear Infirmary (NYEEI) who meet the inclusion criteria will be recruited prospectively. Patients diagnosed with non-infectious uveitis will be asked to self-administer the Perceived Stress Scale (PSS) - 10, following informed consent. Patient demographics will also be collected. The presence of inflammation will be then be assessed by the investigator. Patients will be asked to complete the PSS-10 again at all subsequent standard-of-care visits within a 6-month timeframe. PSS-10 scores are obtained by reversing the scores on the four positive items (4, 5, 7 and 8), then summing across all 10 items. Patient and the investigator will be masked to the PSS scores.
- Conditions
- Uveitis
- Medical subject headings
- Uveitis
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 |
|---|---|---|
| Noninfectious Uveitis | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The New York Eye & Ear Infirmary
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025986
- Sponsor's protocol ID
- NYEE120309
- Status last verified
- Dec 2009
- First submitted
- 3 Dec 2009
- Last updated
- 4 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uveitis in Relation to Perceived Stress: A Prospective Study
- ClinicalTrials.gov ID
- NCT01025986
- Acronym / sponsor ID
- NYEE120309
- Conditions
- Uveitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The New York Eye & Ear InfirmaryUniversity, hospital or other
- Study start
- Jul 2009
- First posted
- 4 Dec 2009 (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.
The purpose of this study is to conduct a prospective analysis to determine the relationship between disease activity of noninfectious uveitis and stress.
Detailed description
Patients presenting at The New York Eye and Ear Infirmary (NYEEI) who meet the inclusion criteria will be recruited prospectively. Patients diagnosed with non-infectious uveitis will be asked to self-administer the Perceived Stress Scale (PSS) - 10, following informed consent. Patient demographics will also be collected. The presence of inflammation will be then be assessed by the investigator. Patients will be asked to complete the PSS-10 again at all subsequent standard-of-care visits within a 6-month timeframe. PSS-10 scores are obtained by reversing the scores on the four positive items (4, 5, 7 and 8), then summing across all 10 items. Patient and the investigator will be masked to the PSS scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noninfectious Uveitis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at the New York Eye and Ear Infirmary diagnosed with uveitis
Key inclusion criteria (2 listed)
- At least 18 years of age with a diagnosis of non-infectious uveitis
- Able to self-administer the Perceived Stress Scale (PSS) - 10
Key exclusion criteria (1 listed)
- Diagnosis of infectious uveitis
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2009.
Related trials for Uveitis
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruiting
Efficacy and Safety of Adalimumab for the Treatment of Ocular Inflammation
Non-infectious Anterior Uveitis, Non-infectious Intermediate Uveitis
RecruitingObservational study
A Study of Uveitis in Children <18 Years of Age
Uveitis
Active, not recruitingPhase 2
Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema
Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative
RecruitingPhase 1
A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious Uveitis
Non Infectious Uveitis
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.
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 Uveitis, run by The New York Eye & Ear Infirmary at 1 site in United States.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Dec 2009. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 4 Dec 2009.