The Cohort Study of Uveitis Patients

The Cohort Study of Uveitis Patients Based on Real-world Data

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.

Study Overview

• Status: Recruiting
• Conditions: Uveitis

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Zhongshan Ophthalmic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population are adult uveitis patients.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Noninfectious uveitis
Infectious uveitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The socre of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system	activity of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system	12 months post-treatment
The range of inflammatory chorioretinal and/or inflammatory retinal vascular lesions	inflammatory chorioretinal and/or inflammatory retinal vascular lesions were evaluated by fundus fluorescein angiography and indocyanine green angiography	12 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity	Best corrected visual acuity	1 month post-treatment
Best corrected visual acuity	Best corrected visual acuity	3 months post-treatment
Best corrected visual acuity	Best corrected visual acuity	6 months post-treatment
Best corrected visual acuity	Best corrected visual acuity	12 months post-treatment
Best corrected visual acuity	Best corrected visual acuity	24 months post-treatment
Best corrected visual acuity	Best corrected visual acuity	36 months post-treatment
Central retinal thickness	Central retinal thickness was evaluated by Optical Coherence Tomography	1 month post-treatment
Central retinal thickness	Central retinal thickness was evaluated by Optical Coherence Tomography	3 months post-treatment
Central retinal thickness	Central retinal thickness was evaluated by Optical Coherence Tomography	6 months post-treatment
Central retinal thickness	Central retinal thickness was evaluated by Optical Coherence Tomography	12 months post-treatment
Central retinal thickness	Central retinal thickness was evaluated by Optical Coherence Tomography	24 months post-treatment
Central retinal thickness	Central retinal thickness was evaluated by Optical Coherence Tomography	36 months post-treatment
The number of intraocular pressure	The number of Intraocular pressure was examed by non-contact tonometer	1 month post-treatment
The number of intraocular pressure	The number of Intraocular pressure was examed by non-contact tonometer	3 months post-treatment
The number of intraocular pressure	The number of Intraocular pressure was examed by non-contact tonometer	6 months post-treatment
The number of Intraocular pressure	The number of Intraocular pressure was examed by non-contact tonometer	12 months post-treatment
The number of Intraocular pressure	The number of Intraocular pressure was examed by non-contact tonometer	24 months post-treatment
The number of Intraocular pressure	The number of Intraocular pressure was examed by non-contact tonometer	36 months post-treatment
The socre of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system	activity of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system	1 month post-treatment
The socre of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system	activity of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system	3 months post-treatment
The socre of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system	activity of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system	6 months post-treatment
The socre of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system	activity of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system	24 months post-treatment
The socre of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system	activity of anterior chamber inflammation based on the Standardization of Uveitis Nomenclature (SUN) scoring system	36 months post-treatment
The range of inflammatory chorioretinal and/or inflammatory retinal vascular lesions	inflammatory chorioretinal and/or inflammatory retinal vascular lesions were evaluated by fundus fluorescein angiography and indocyanine green angiography	3 months post-treatment
The range of inflammatory chorioretinal and/or inflammatory retinal vascular lesions	inflammatory chorioretinal and/or inflammatory retinal vascular lesions were evaluated by fundus fluorescein angiography and indocyanine green angiography	6 months post-treatment
The range of inflammatory chorioretinal and/or inflammatory retinal vascular lesions	inflammatory chorioretinal and/or inflammatory retinal vascular lesions were evaluated by fundus fluorescein angiography and indocyanine green angiography	24 months post-treatment
The range of inflammatory chorioretinal and/or inflammatory retinal vascular lesions	inflammatory chorioretinal and/or inflammatory retinal vascular lesions were evaluated by fundus fluorescein angiography and indocyanine green angiography	36 months post-treatment

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Anticipated): February 20, 2026
• Study Completion (Anticipated): March 31, 2026

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: IIT2022146

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No