UveitisACID LTRNCT04193020
Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response
An observational study of Uveitis, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
Acute and chronic inflammatory eye diseases are difficult to diagnose and maintain quiescent with therapy. Proposed study is aimed to find on the one hand, novel factors for recurrence of the disease or remission of inflammation and evaluation of the impact of lifestyle and known factors on the other. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Uveitis
- What is being tested?
- Surveillance card
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2020to 1 Jan 2026
- How long will I take part?
- 10 Years
- 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: Any patient with a new diagnosis or a recurrence of uni or bilateral uveitis.
Who may be able to join
- new diagnosis of uni or bilateral uveitis
- recurrence of the diagnosed previously uni or bilateral uveitis
Who cannot join
- not mentally able to reply the questionnaire
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Ophthalmology
Wroclaw, 54-622
Joanna Przeździecka-Dołyk, PhD
About this study
Official title: Impact of Lifestyle and Treatment on the Recurrency and Severity of Acute and Chronic Inflamatory Eye Diseases: Protocol on Prospective Cohort Study
Acute and chronic inflammatory eye diseases are difficult to diagnose and maintain quiescent with therapy. Proposed study is aimed to find on the one hand, novel factors for recurrence of the disease or remission of inflammation and evaluation of the impact of lifestyle and known factors on the other.
Each patient is treated in accordance to the best of medical knowledge and guidelines for each disease.
Read more
This prospective cohort study will enroll uveitic patients to the steroid only group (SG), combined (steroid and adjuvant drug) group (CG) or bilogic therapy group (BTG).
At baseline, patient data are recorded using patient-reported outcome measures and clinical assessments (ophthalomology) on disease activity (clinical scales), quality of life, and lifestyle together with registry data on comorbidity and medication. During follow-up evaluation of a successful treatment outcome response will be based on clinical scales and most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients in different treatment group.
- Conditions
- Uveitis
- Being tested
- Surveillance card
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveillance cardOther
Surveillance card and additional examination to find novel markers and better assess the existing ones
| Study group | Role | What they receive |
|---|---|---|
| steroid only group (SG) | Not described Receives: Other: Surveillance card | |
| combined (steroid and adjuvant drug) group (CG) | Not described Receives: Other: Surveillance card | |
| bilogic therapy group (BTG) | Not described Receives: Other: Surveillance card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
Total number of treatment success in each group
Measured: 1 year
Recurrence time
Time to the next recurrence after the treatment regimen introduction
Measured: 10 years
Severe visual loss
Time and cause of severe visual loss
Measured: 10 years
Secondary outcomes (7)
ETDRS Visual Acuity
Visual Acuity will be performed with ETDRS charts different for right and left eye
Measured: 10 years
The SUN working group grading system for anterior chamber cells
At each visit anterior chamber will be examined to assess anterior chamber cells (1mm x 1mm slit beam in height and width, when thrown at an angle of 45-60°). The recorded number of cells will be used to determine the grade according to the SUN criteria.
Measured: 10 years
The SUN working group grading system for anterior chamber flare
At each visit anterior chamber will be examined to assess anterior chamber flare (1mm x 1mm slit beam in height and width, when thrown at an angle of 45-60°). The observed changes will be used to determine the grade according to the SUN criteria.
Measured: 10 years
AREDS 2008 Clinical Lens Opacity Grading Procedure
Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded.
Measured: 10 years
NIH grading system for vitreous cells
At each visit vitreous will be examined to assess vitreous cells (1mm x 3mm slit beam in anterior vitreous). The recorded number of cells will be used to determine the grade according to the NIH criteria.
Measured: 10 years
NIH grading system for vitreous haze
At each visit vitreous will be examined to assess vitreous haze. The recorded of clarity of posterior pole funduscopy will be used to determine the grade according to the NIH criteria.
Measured: 10 years
Submacular choroidal thickness
OCT EDI recordings processed with developed by researchers methodology for image processing.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Jan 2020
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
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
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Wrocław University of Science and Technology
- Responsible party
- Principal investigator, Joanna Przeździecka-Dołyk, Wroclaw Medical University
- Investigators
- Marta Misiuk-Hojło, Professor, Study chair, Medical University of Wrocław
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193020
- Sponsor's protocol ID
- ST-859
- Acronym
- ACID LTR
- Status last verified
- Apr 2021
- First submitted
- 7 Dec 2019
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing coded data such as BCVA, intraocular preassure, visual functioning questionaire responses, anterior chamber cells and flare scales records as well as lens opacity grading records.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lifestyle and Treatment on the Recurrency and Severity of Acute and Chronic Inflamatory Eye Diseases: Protocol on Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04193020
- Acronym / sponsor ID
- ACID LTR / ST-859
- Conditions
- Uveitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- Wrocław University of Science and Technology
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 10 Dec 2019 (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.
Acute and chronic inflammatory eye diseases are difficult to diagnose and maintain quiescent with therapy. Proposed study is aimed to find on the one hand, novel factors for recurrence of the disease or remission of inflammation and evaluation of the impact of lifestyle and known factors on the other.
Each patient is treated in accordance to the best of medical knowledge and guidelines for each disease.
This prospective cohort study will enroll uveitic patients to the steroid only group (SG), combined (steroid and adjuvant drug) group (CG) or bilogic therapy group (BTG).
At baseline, patient data are recorded using patient-reported outcome measures and clinical assessments (ophthalomology) on disease activity (clinical scales), quality of life, and lifestyle together with registry data on comorbidity and medication. During follow-up evaluation of a successful treatment outcome response will be based on clinical scales and most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients in different treatment group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| steroid only group (SG) | – | Other: Surveillance card |
| combined (steroid and adjuvant drug) group (CG) | – | Other: Surveillance card |
| bilogic therapy group (BTG) | – | Other: Surveillance card |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient with a new diagnosis or a recurrence of uni or bilateral uveitis.
Key inclusion criteria (2 listed)
- new diagnosis of uni or bilateral uveitis
- recurrence of the diagnosed previously uni or bilateral uveitis
Key exclusion criteria (1 listed)
- not mentally able to reply the questionnaire
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 |
|---|---|---|
| Surveillance cardSurveillance card and additional examination to find novel markers and better assess the existing ones | Other | bilogic therapy group (BTG), combined (steroid and adjuvant drug) group (CG), steroid only group (SG) |
Primary outcome
Treatment success
Time frame: 1 year
Total number of treatment success in each group
Recurrence time
Time frame: 10 years
Time to the next recurrence after the treatment regimen introduction
Severe visual loss
Time frame: 10 years
Time and cause of severe visual loss
7 secondary outcomes
ETDRS Visual Acuity
Time frame: 10 years
The SUN working group grading system for anterior chamber cells
Time frame: 10 years
The SUN working group grading system for anterior chamber flare
Time frame: 10 years
AREDS 2008 Clinical Lens Opacity Grading Procedure
Time frame: 10 years
NIH grading system for vitreous cells
Time frame: 10 years
NIH grading system for vitreous haze
Time frame: 10 years
Submacular choroidal thickness
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: Undecided. Sharing coded data such as BCVA, intraocular preassure, visual functioning questionaire responses, anterior chamber cells and flare scales records as well as lens opacity grading records.
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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.
Marta Misiuk-Hojło, Professor study chair
Medical University of Wrocław
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 Wroclaw Medical University at 1 site in Poland.
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 20 Apr 2021. 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 Poland. 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?
Contact Joanna Przeździecka-Dołyk, PhD (+49605693022, joanna.przezdziecka-dolyk@umed.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success (time frame: 1 year). The study lists 3 primary outcomes in all. 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 20 Apr 2021.