NCT04193020

Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response

Impact of Lifestyle and Treatment on the Recurrency and Severity of Acute and Chronic Inflamatory Eye Diseases: Protocol on Prospective Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Wroclaw Medical University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Uveitis

Interventions

Type	Name	Description
OTHER	Surveillance card	Surveillance card and additional examination to find novel markers and better assess the existing ones

Timeline

• Start date: 2020-01-01
• Primary completion: 2025-01-01
• Completion: 2026-01-01
• First posted: 2019-12-10
• Last updated: 2021-04-20

Locations

1 site across 1 country: Poland