The Cohort Study of Uveitis Patients

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05727540
Collaborator
(none)
600
1
37.3
16.1

Study Details

Study Description

Brief Summary

This study intends to explore the epidemiology, pathogenesis, clinical manifestations, diagnosis and treatment of uveitis. This is a cohort study. The outcome of the study is the activity of inflammation and visual prognosis. The purpose of this study is to determine the optimal diagnosis and treatment scheme for uveitis patients based on real-world data.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Cohort Study of Uveitis Patients Based on Real-world Data
    Anticipated Study Start Date :
    Feb 20, 2023
    Anticipated Primary Completion Date :
    Feb 20, 2026
    Anticipated Study Completion Date :
    Mar 31, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    Noninfectious uveitis

    Infectious uveitis

    Outcome Measures

    Primary Outcome Measures

    1. anterior chamber inflammation [12 months post-treatment]

      activity of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system

    2. inflammatory chorioretinal and/or inflammatory retinal vascular lesions [12 months post-treatment]

      inflammatory chorioretinal and/or inflammatory retinal vascular lesions were evaluated by fundus fluorescein angiography and indocyanine green angiography

    Secondary Outcome Measures

    1. Best corrected visual acuity [1 month post-treatment]

      Best corrected visual acuity

    2. Best corrected visual acuity [3 months post-treatment]

      Best corrected visual acuity

    3. Best corrected visual acuity [6 months post-treatment]

      Best corrected visual acuity

    4. Best corrected visual acuity [12 months post-treatment]

      Best corrected visual acuity

    5. Best corrected visual acuity [24 months post-treatment]

      Best corrected visual acuity

    6. Best corrected visual acuity [36 months post-treatment]

      Best corrected visual acuity

    7. Intraocular pressure [1 month post-treatment]

      Intraocular pressure

    8. Intraocular pressure [3 months post-treatment]

      Intraocular pressure

    9. Intraocular pressure [6 months post-treatment]

      Intraocular pressure

    10. Intraocular pressure [12 months post-treatment]

      Intraocular pressure

    11. Intraocular pressure [24 months post-treatment]

      Intraocular pressure

    12. Intraocular pressure [36 months post-treatment]

      Intraocular pressure

    13. Central retinal thickness [1 month post-treatment]

      Central retinal thickness was evaluated by Optical Coherence Tomography

    14. Central retinal thickness [3 months post-treatment]

      Central retinal thickness was evaluated by Optical Coherence Tomography

    15. Central retinal thickness [6 months post-treatment]

      Central retinal thickness was evaluated by Optical Coherence Tomography

    16. Central retinal thickness [12 months post-treatment]

      Central retinal thickness was evaluated by Optical Coherence Tomography

    17. Central retinal thickness [24 months post-treatment]

      Central retinal thickness was evaluated by Optical Coherence Tomography

    18. Central retinal thickness [36 months post-treatment]

      Central retinal thickness was evaluated by Optical Coherence Tomography

    19. anterior chamber inflammation [1 month post-treatment]

      activity of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system

    20. anterior chamber inflammation [3 months post-treatment]

      activity of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system

    21. anterior chamber inflammation [6 months post-treatment]

      activity of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system

    22. anterior chamber inflammation [24 months post-treatment]

      activity of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system

    23. anterior chamber inflammation [36 months post-treatment]

      activity of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system

    24. inflammatory chorioretinal and/or inflammatory retinal vascular lesions [3 months post-treatment]

      inflammatory chorioretinal and/or inflammatory retinal vascular lesions were evaluated by fundus fluorescein angiography and indocyanine green angiography

    25. inflammatory chorioretinal and/or inflammatory retinal vascular lesions [6 months post-treatment]

      inflammatory chorioretinal and/or inflammatory retinal vascular lesions were evaluated by fundus fluorescein angiography and indocyanine green angiography

    26. inflammatory chorioretinal and/or inflammatory retinal vascular lesions [24 months post-treatment]

      inflammatory chorioretinal and/or inflammatory retinal vascular lesions were evaluated by fundus fluorescein angiography and indocyanine green angiography

    27. inflammatory chorioretinal and/or inflammatory retinal vascular lesions [36 months post-treatment]

      inflammatory chorioretinal and/or inflammatory retinal vascular lesions were evaluated by fundus fluorescein angiography and indocyanine green angiography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • The diagnosis is uveitis; The agreement of enrolling this study;
    Exclusion Criteria:
    • Uveitis during the first month after any intraocular surgery; <18 years; pregnant and lactating women; other conditions are unsuitable for participation in this study by the investigator such as mental abnormalities.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Ophthalmic Center Guangzhou Guangdong China

    Sponsors and Collaborators

    • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05727540
    Other Study ID Numbers:
    • IIT2022146
    First Posted:
    Feb 14, 2023
    Last Update Posted:
    Feb 14, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 14, 2023