Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response (ACID LTR)
16. april 2021 oppdatert av: 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.
Studieoversikt
Studietype
Observasjonsmessig
Registrering (Forventet)
300
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Joanna Przeździecka-Dołyk, PhD
- Telefonnummer: +49605693022
- E-post: joanna.przezdziecka-dolyk@umed.wroc.pl
Studiesteder
-
-
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Wrocław, Polen, 54-622
- Rekruttering
- Department of Ophthalmology
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Any patient with a new diagnosis or a recurrence of uni or bilateral uveitis.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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)
|
Surveillance card and additional examination to find novel markers and better assess the existing ones
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment success
Tidsramme: 1 year
|
Total number of treatment success in each group
|
1 year
|
|
Recurrence time
Tidsramme: 10 years
|
Time to the next recurrence after the treatment regimen introduction
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10 years
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Severe visual loss
Tidsramme: 10 years
|
Time and cause of severe visual loss
|
10 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
ETDRS Visual Acuity
Tidsramme: 10 years
|
Visual Acuity will be performed with ETDRS charts different for right and left eye
|
10 years
|
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The SUN working group grading system for anterior chamber cells
Tidsramme: 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.
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10 years
|
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The SUN working group grading system for anterior chamber flare
Tidsramme: 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.
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10 years
|
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AREDS 2008 Clinical Lens Opacity Grading Procedure
Tidsramme: 10 years
|
Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded.
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10 years
|
|
NIH grading system for vitreous cells
Tidsramme: 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
Tidsramme: 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.
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10 years
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Submacular choroidal thickness
Tidsramme: 10 years
|
OCT EDI recordings processed with developed by researchers methodology for image processing.
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10 years
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
COVID-19 confirmed infection asymptomatic patient
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
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1 year
|
|
Ocular Surface Disease Index
Tidsramme: 1 year
|
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
|
1 year
|
|
Dry Eye Questionnaire
Tidsramme: 1 year
|
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
Tidsramme: 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
|
|
LIKERT Questionnaire
Tidsramme: 1 year
|
LIKER Questionnaire that assess the frequency, severity of symptoms and infuence of symptoms on the patient day-to-day activities during the treatment.
|
1 year
|
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LIPCOF scale
Tidsramme: 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
Tidsramme: 1 year
|
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
Tidsramme: 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.
|
1 year
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2020
Primær fullføring (Forventet)
1. januar 2025
Studiet fullført (Forventet)
1. januar 2026
Datoer for studieregistrering
Først innsendt
7. desember 2019
Først innsendt som oppfylte QC-kriteriene
7. desember 2019
Først lagt ut (Faktiske)
10. desember 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ST-859
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ubestemt
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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