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Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response (ACID LTR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193020
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : April 10, 2020
Sponsor:
Collaborator:
Wrocław University of Science and Technology
Information provided by (Responsible Party):
Joanna Przeździecka-Dołyk, Wroclaw Medical University

Brief 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.

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.


Condition or disease Intervention/treatment
Uveitis Other: Surveillance card

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Impact of Lifestyle and Treatment on the Recurrency and Severity of Acute and Chronic Inflamatory Eye Diseases: Protocol on Prospective Cohort Study
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Group/Cohort Intervention/treatment
steroid only group (SG) Other: Surveillance card
Surveillance card and additional examination to find novel markers and better assess the existing ones

combined (steroid and adjuvant drug) group (CG) Other: Surveillance card
Surveillance card and additional examination to find novel markers and better assess the existing ones

bilogic therapy group (BTG) Other: Surveillance card
Surveillance card and additional examination to find novel markers and better assess the existing ones




Primary Outcome Measures :
  1. Treatment success [ Time Frame: 1 year ]
    Total number of treatment success in each group

  2. Recurrence time [ Time Frame: 10 years ]
    Time to the next recurrence after the treatment regimen introduction

  3. Severe visual loss [ Time Frame: 10 years ]
    Time and cause of severe visual loss


Secondary Outcome Measures :
  1. ETDRS Visual Acuity [ Time Frame: 10 years ]
    Visual Acuity will be performed with ETDRS charts different for right and left eye

  2. The SUN working group grading system for anterior chamber cells [ Time Frame: 10 years ]
    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.

  3. The SUN working group grading system for anterior chamber flare [ Time Frame: 10 years ]
    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.

  4. AREDS 2008 Clinical Lens Opacity Grading Procedure [ Time Frame: 10 years ]
    Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded.

  5. NIH grading system for vitreous cells [ Time Frame: 10 years ]
    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.

  6. NIH grading system for vitreous haze [ Time Frame: 10 years ]
    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.

  7. Submacular choroidal thickness [ Time Frame: 10 years ]
    OCT EDI recordings processed with developed by researchers methodology for image processing.


Other Outcome Measures:
  1. COVID-19 confirmed infection asymptomatic patient [ Time Frame: 1 year ]
    PCR-positive result of COVID-19 specific testing, no treatment required

  2. COVID-19 confirmed infection [ Time Frame: 1 year ]
    PCR-positive result of COVID-19 specific testing, patient require treatment. The mode of treatment will be recorded into several groups: 1) antibiotics, 2) antivirals, 3) biologic treatment, 4) immunoglobulins, 5) steroids

  3. COVID-19 related acute respiratory distress syndrome (ARDS) [ Time Frame: 1 year ]
    COVID-19 related acute respiratory distress syndrome (ARDS). Situation in which patients need any of described below: 1) supportive oxygen therapy, 2) non-invasive ventilation, 3) invasive/ mechanical ventilation, 4) use of ECMO, 5) admission to intensive care unit, 6) dialysis



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any patient with a new diagnosis or a recurrence of uni or bilateral uveitis.
Criteria

Inclusion Criteria:

  • new diagnosis of uni or bilateral uveitis
  • recurrence of the diagnosed previously uni or bilateral uveitis

Exclusion Criteria:

  • not mentally able to reply the questionnaire

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193020


Contacts
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Contact: Joanna Przeździecka-Dołyk, PhD +49605693022 joanna.przezdziecka-dolyk@umed.wroc.pl

Locations
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Poland
Department of Ophthalmology Recruiting
Wrocław, Poland, 54-622
Contact: Joanna Przeździecka-Dołyk, PhD         
Sponsors and Collaborators
Wroclaw Medical University
Wrocław University of Science and Technology
Investigators
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Study Chair: Marta Misiuk-Hojło, Professor Medical University of Wrocław
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Responsible Party: Joanna Przeździecka-Dołyk, Principal Investigator, Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT04193020    
Other Study ID Numbers: ST-859
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases