Pathogen Detection in Infectious Uveitis

Pathogen Detection in Infectious Uveitis in China

Infectious uveitis is a very important blinding disease. Some people who have been diagnosed with idiopathic uveitis may also have the activity of pathogens in the eye. However, due to the limitation of the amount of ocular samples, it is difficult to make a rapid and effective diagnosis of infection.Current study is to explore the infective cause of uveitis in China by using a broad diagnostic approach of detection.

Study Overview

• Status: Unknown
• Conditions: Infectious Panuveitis; Infectious Iridocyclitis

Detailed Description

Infectious uveitis is a very important blinding disease. Some people who have been diagnosed with idiopathic uveitis may also have the activity of pathogens in the eye. However, due to the limitation of the amount of ocular samples, it is difficult to make a rapid and effective diagnosis of infection.

The study is to explore the infective cause of uveitis in China by using a broad diagnostic approach of detection, including multiple molecular bio-techniques. We also plan to explore the distribution of pathogens in infectious uveitis.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Ping Fei, MD,PhD; Phone Number: 86-13636342098; Email: shirleypingfei@126.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Xinhua Hospital
    • Contact: Ping Fei; Phone Number: 86-13636342098
    • Principal Investigator: Ping Fei, MD，PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient at a referal hospital eye clinic with clinically suspected infectious uveitis, who undergo AC tap or diagnostic vitrectomy

Description

Inclusion Criteria:

• Patient at a referal hospital eye clinic with clinically suspected infectious uveitis

Exclusion Criteria:

• Patients not eligible for the Inclusion Criteria
• Confirmed auto-immune uveitis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
infectious uveitis; Patients suffering from suspected infectious uveitis, who have vitrectomy performed for diagnostic purpose or anterior chamber tap
Control group; Patients suffering from either cataract surgery or vitrectomy who has been ruled out for infectious ocular diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence and distribution of intraocular infections in the study group	Prevalence and distribution of intraocular infections in the study group	Oct 2020 to Sep 2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The sensitivity and specificity of multiple molecular diagnostic methods for detection of bacteria or virus fungi in the study group	The sensitivity and specificity of multiple molecular diagnostic methods for detection of bacteria or virus fungi in the study group	Oct 2020 to Sep 2022

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Ping Fei, MD，PhD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: PCR; pathogen; infectious uveitis
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Uveitis, Anterior; Uveal Diseases; Iris Diseases; Infections; Communicable Diseases; Uveitis; Panuveitis; Iridocyclitis
• Other Study ID Numbers: XH-20-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 2 years after the study
• IPD Sharing Access Criteria: if required propriately
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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