Intraocular Fluid Detection in Endophthalmitis

NCT04914884 | Unknown

• 1 other identifier: I2020001874
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraocular Inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

intraocular inflammation group

Diagnostic Test: intraocular fluid detection

Cataract patients group

Diagnostic Test: intraocular fluid detection

Interventions

intraocular fluid detection DIAGNOSTIC_TEST

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; intraocular inflammation group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 7, 2021
• Study Start: June 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: January 1, 2022
• Last Updated: June 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)