UveitisNCT03753893
Ocular Manifestations in Rheumatic Diseases
An observational study of Uveitis and Conjunctivitis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
This is a search strategy for determining the prevalence of ocular complications in inflammatory rheumatic diseases for the purposes of a meta analysis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Uveitis, Conjunctivitis, Keratoconjunctivitis Sicca
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 1 Nov 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with ocular involvement in inflammatory rheumatic disease
Who may be able to join
- Studies were included if they provided numerical data of the prevalence or incidence of ocular manifestations in inflammatory rheumatic disease
Who cannot join
- review articles,
- case reports where all patients experienced the same ocular comorbidity
- if different comorbidities were not grouped independently
- if the study reported on fewer than 20 patients
About this study
Official title: Prevalence of Ocular Manifestations in Inflammatory Rheumatic Diseases
This is a search strategy for determining the prevalence of ocular complications in inflammatory rheumatic diseases for the purposes of a meta analysis.
Read the detailed description
For the purposes of determining the prevalence of ocular complications in inflammatory rheumatic diseases, the following search terms were used: conjunctivitis, keratoconjunctivitis sicca, xerophthalmia, uveitis, eye hemorrhage, optic neuritis, papilledema, orbital disease, retinal artery/vein occlusion, macular edema, retinitis, chorioretinitis, scleritis, iridocyclitis, choroid hemorrhage, blindness and amaurosis fugax.
These terms were searched in the context of a corresponding inflammatory disease on Medline, Cochrane and Web of Science from their inception (1966, 1991 and 1990 respectively) until the point of study completion.
Studies were included if they provided numerical data of the prevalence or incidence of ocular manifestations in an inflammatory rheumatic disease. Studies were excluded if they were review articles, case reports where all patients experienced the same ocular comorbidity, if different comorbidities were not grouped independently, and if the study reported on fewer than 20 patients. When the same study cohort was used in more than one analysis, the most recent or largest sample-size study was included. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist was used to assess the quality of cohort, case-control, and cross-sectional studies.
- Conditions
- Uveitis, Conjunctivitis, Keratoconjunctivitis Sicca, Xerophthalmia, Eye Hemorrhage, Optic Neuritis
- Being tested
- No intervention used
- Medical subject headings
- Uveitis, Conjunctivitis, Keratoconjunctivitis Sicca, Xerophthalmia, Eye Hemorrhage, Optic Neuritis, Papilledema, Orbital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention usedOther
no intervention used
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ocular manifestations of inflammatory rheumatic diseases
Prevalence of ocular manifestations of inflammatory rheumatic diseases
Measured: data is collected once per year up to 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 May 2013
- Primary completion1 Apr 2021
- Study completion1 Nov 2021
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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Pope, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Janet Pope, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753893
- Sponsor's protocol ID
- MTJP001
- Status last verified
- Apr 2022
- First submitted
- 31 Oct 2018
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Ocular Manifestations in Inflammatory Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT03753893
- Acronym / sponsor ID
- MTJP001
- Conditions
- Uveitis, Conjunctivitis, Keratoconjunctivitis Sicca, Xerophthalmia, Eye Hemorrhage, Optic Neuritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 27 Nov 2018 (actual)
- 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.
This is a search strategy for determining the prevalence of ocular complications in inflammatory rheumatic diseases for the purposes of a meta analysis.
Detailed description
For the purposes of determining the prevalence of ocular complications in inflammatory rheumatic diseases, the following search terms were used: conjunctivitis, keratoconjunctivitis sicca, xerophthalmia, uveitis, eye hemorrhage, optic neuritis, papilledema, orbital disease, retinal artery/vein occlusion, macular edema, retinitis, chorioretinitis, scleritis, iridocyclitis, choroid hemorrhage, blindness and amaurosis fugax.
These terms were searched in the context of a corresponding inflammatory disease on Medline, Cochrane and Web of Science from their inception (1966, 1991 and 1990 respectively) until the point of study completion.
Studies were included if they provided numerical data of the prevalence or incidence of ocular manifestations in an inflammatory rheumatic disease. Studies were excluded if they were review articles, case reports where all patients experienced the same ocular comorbidity, if different comorbidities were not grouped independently, and if the study reported on fewer than 20 patients. When the same study cohort was used in more than one analysis, the most recent or largest sample-size study was included. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist was used to assess the quality of cohort, case-control, and cross-sectional studies.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ocular involvement in inflammatory rheumatic disease
Key inclusion criteria (1 listed)
- Studies were included if they provided numerical data of the prevalence or incidence of ocular manifestations in inflammatory rheumatic disease
Key exclusion criteria (4 listed)
- review articles,
- case reports where all patients experienced the same ocular comorbidity
- if different comorbidities were not grouped independently
- if the study reported on fewer than 20 patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention usedno intervention used | Other | – |
Primary outcome
Prevalence of ocular manifestations of inflammatory rheumatic diseases
Time frame: data is collected once per year up to 2020
Prevalence of ocular manifestations of inflammatory rheumatic diseases
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 12 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Janet Pope, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis and Conjunctivitis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 1 inclusion and 4 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 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Prevalence of ocular manifestations of inflammatory rheumatic diseases (time frame: data is collected once per year up to 2020). It is what the study was designed to measure, not a finding.
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 12 Apr 2022.