Clinical trial NCT04914884: Intraocular Fluid Detection in Endophthalmitis
Official title: Clinical Application of Intraocular Fluid Detection in Endophthalmitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraocular Inflammation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The intraocular fluid of patients with endophthalmitis and age-related cataract were collected
timeFrame: 2021.1-2021.6
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
Study officials:
References: