Intraocular Fluid Detection in Endophthalmitis

Clinical Application of Intraocular Fluid Detection in Endophthalmitis

Endophthalmitis is also called vitreous inflammation. Broadly speaking, it refers to all kinds of serious intraocular inflammation, such as vitreitis, anterior chamber empyema and eye pain caused by intraocular infection, intraocular foreign body, tumor necrosis, severe non infectious uveitis, lens cortex allergy, etc. Clinically, it generally refers to infectious endophthalmitis caused by bacteria, fungi or parasites. According to the different ways of infection, it can be divided into exogenous endophthalmitis and endogenous endophthalmitis. Exogenous endophthalmitis is more common. When inflammation involves sclera or extraocular orbital tissue, it is called "panophthalmia".

Endophthalmitis is a kind of serious intraocular inflammation which can lead to the loss of visual function. Early diagnosis and treatment is the key. Studies have found that the changes of cytokines in aqueous humor are helpful for the diagnosis of endophthalmitis. Okhrvai et al. Also pointed out that the application of PCR can reduce the diagnosis time of endophthalmitis. This study mainly verified the use of molecular biology technology to detect the changes of VCAM, ICAM-1 and other cytokines, bacteria, viruses, fungi, Toxoplasma gondii IgG in patients' intraocular fluid, including aqueous humor and vitreous humor, so as to timely judge the etiology and progress of endophthalmitis, and provide reference for diagnosis and treatment.

Study Overview

• Status: Active, not recruiting
• Conditions: Intraocular Inflammation
• Intervention / Treatment: Diagnostic test: intraocular fluid detection

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

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

According to the formula n = Z2 * (p * (1-p)) / E2, the confidence is 95%, the error is 10%, and the probability is 0.5. The sample size is calculated to be 96 cases. According to some similar literatures, the sample size is set to be 100 cases.

Description

Inclusion Criteria:

• ① Clinical manifestations: eye pain, photophobia and tears, decreased vision, conjunctival congestion and edema, etc. ② Special examination: anterior examination showed conjunctival congestion and edema, postkeratosis, anterior chamber empyema and other inflammatory manifestations. Fundus examination showed vitreous opacity, fundus hemorrhage and white lesions. ③ Laboratory examination: bacteria, viruses, fungi and Toxoplasma gondii were detected in the aqueous humor and vitreous humor of the patients.

Exclusion Criteria:

• 1. With tumor, rheumatoid and other autoimmune diseases. 2. Accompanied by diabetes and other systemic chronic diseases. 3. Patients with retinal and choroidal vascular diseases and history of eye surgery were excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
intraocular inflammation group	Diagnostic test: intraocular fluid detection; This study mainly verified the use of molecular biology technology to detect the changes of VCAM, ICAM-1 and other cytokines, bacteria, viruses, fungi, Toxoplasma gondii IgG in patients' intraocular fluid, including aqueous humor and vitreous humor, so as to timely judge the etiology and progress of endophthalmitis, and provide reference for diagnosis and treatment.
Cataract patients group	Diagnostic test: intraocular fluid detection; This study mainly verified the use of molecular biology technology to detect the changes of VCAM, ICAM-1 and other cytokines, bacteria, viruses, fungi, Toxoplasma gondii IgG in patients' intraocular fluid, including aqueous humor and vitreous humor, so as to timely judge the etiology and progress of endophthalmitis, and provide reference for diagnosis and treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The intraocular fluid of patients with endophthalmitis and age-related cataract were collected	to check the cytokines in the intraocular fluid	2021.1-2021.6

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Eye Diseases; Uveal Diseases; Eye Infections; Inflammation; Uveitis; Endophthalmitis
• Other Study ID Numbers: I2020001874

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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