Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response (ACID LTR)
16 april 2021 bijgewerkt door: Joanna Przeździecka-Dołyk, Wroclaw Medical University
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.
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.
Studie Overzicht
Studietype
Observationeel
Inschrijving (Verwacht)
300
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Joanna Przeździecka-Dołyk, PhD
- Telefoonnummer: +49605693022
- E-mail: joanna.przezdziecka-dolyk@umed.wroc.pl
Studie Locaties
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Wrocław, Polen, 54-622
- Werving
- Department of Ophthalmology
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Any patient with a new diagnosis or a recurrence of uni or bilateral uveitis.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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steroid only group (SG)
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Surveillance card and additional examination to find novel markers and better assess the existing ones
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combined (steroid and adjuvant drug) group (CG)
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Surveillance card and additional examination to find novel markers and better assess the existing ones
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bilogic therapy group (BTG)
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Surveillance card and additional examination to find novel markers and better assess the existing ones
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Treatment success
Tijdsspanne: 1 year
|
Total number of treatment success in each group
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1 year
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Recurrence time
Tijdsspanne: 10 years
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Time to the next recurrence after the treatment regimen introduction
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10 years
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Severe visual loss
Tijdsspanne: 10 years
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Time and cause of severe visual loss
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10 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
ETDRS Visual Acuity
Tijdsspanne: 10 years
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Visual Acuity will be performed with ETDRS charts different for right and left eye
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10 years
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The SUN working group grading system for anterior chamber cells
Tijdsspanne: 10 years
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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.
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10 years
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The SUN working group grading system for anterior chamber flare
Tijdsspanne: 10 years
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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.
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10 years
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AREDS 2008 Clinical Lens Opacity Grading Procedure
Tijdsspanne: 10 years
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Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded.
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10 years
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NIH grading system for vitreous cells
Tijdsspanne: 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.
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10 years
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NIH grading system for vitreous haze
Tijdsspanne: 10 years
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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.
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10 years
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Submacular choroidal thickness
Tijdsspanne: 10 years
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OCT EDI recordings processed with developed by researchers methodology for image processing.
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10 years
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
COVID-19 confirmed infection asymptomatic patient
Tijdsspanne: 1 year
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PCR-positive result of COVID-19 specific testing, no treatment required
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1 year
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COVID-19 confirmed infection
Tijdsspanne: 1 year
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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
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1 year
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COVID-19 related acute respiratory distress syndrome (ARDS)
Tijdsspanne: 1 year
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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
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1 year
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Ocular Surface Disease Index
Tijdsspanne: 1 year
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Ocular Surface Disease Index (OSDI) questionaire results are used to define if during the course of the disease the dry eye syndrom occurs.
Used with subclasses describing the vision-related functions, ocular symptoms, environmental triggers
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1 year
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Dry Eye Questionnaire
Tijdsspanne: 1 year
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Dry Eye Questionnaire (DEQ 5) questionaire results are used to define if during the course of the disease the dry eye syndrom occurs.
Used with subscales describing the eye dyscomfort, eye dryness and watery eyes.
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1 year
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SANDE Questionnaire
Tijdsspanne: 1 year
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SANDE Questionnaire that assess the frequency and severity of symptoms during the treatment.
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1 year
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LIKERT Questionnaire
Tijdsspanne: 1 year
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LIKER Questionnaire that assess the frequency, severity of symptoms and infuence of symptoms on the patient day-to-day activities during the treatment.
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1 year
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LIPCOF scale
Tijdsspanne: 1 year
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Assesment of conjunctival folds according to pre-defined scale.
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1 year
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OXFORD scale
Tijdsspanne: 1 year
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OXFORD scale conducted with instalation of 2 microliters of 2% fluorescite into the conjunctival sac and assessment according to the pre-defined scale.
The subscales for nasal, temporal and lower lid conjunctiva as well as for cornea was used.
The scale has been conducted during the treatment period and if necessary during additional visits.
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1 year
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SICCA scale
Tijdsspanne: 1 year
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SICCA scale conducted with instalation of 2 microliters of 2% fluorescite into the conjunctival sac and assessment of cornea according to the pre-defined scale.
Different dye was used for conjunctica (lizamine green).
The subscales for nasal and temporal conjunctiva as well as for cornea was used.
The scale has been conducted during the treatment period and if necessary during additional visits.
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1 year
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2020
Primaire voltooiing (Verwacht)
1 januari 2025
Studie voltooiing (Verwacht)
1 januari 2026
Studieregistratiedata
Eerst ingediend
7 december 2019
Eerst ingediend dat voldeed aan de QC-criteria
7 december 2019
Eerst geplaatst (Werkelijk)
10 december 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 april 2021
Laatste update ingediend die voldeed aan QC-criteria
16 april 2021
Laatst geverifieerd
1 april 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ST-859
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Onbeslist
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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