Clinical trial NCT06243497: Comparison of Cytokines Profile in Aqueous Humor and Tear Before and After UCP Treatment
Official title: Comparison of Cytokines Profile in Aqueous Humor and Tear Before and After UCP Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glaucoma
Ultrasound Cyclo Plasty
Aqueous Humor
Tear
Cytokines
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatient sample

Brief summary: Glaucoma is the leading cause of irreversible vision loss in people aged 50 years and older worldwide, second only to cataracts. Ultrasound Cyclo Plasty was first proposed as a new minimally invasive technique in the 1980 s. In recent years, many clinical studies at home and abroad have confirmed the effectiveness, safety and repeatability of UCP. The ciliary body is the target organ of UCP, and the range and accuracy of intraoperative destruction of the ciliary body are the key factors affecting the success or failure of the operation. The production of aqueous humor is closely related to the ciliary body. The dynamic balance of its production and discharge can affect IOP, and its content can directly reflect the intraocular environment. Besides,tears are easy to collect and can be used for follow-up. Previous studies have shown that various proteins in aqueous humor or tear can provide a basis for the pathophysiological changes of glaucoma, and can also be a potential biomarker for predicting the success of anti-glaucoma surgery.

At present, UCP related research focuses on its effectiveness and safety, mainly reflected in three aspects : postoperative intraocular pressure, number of anti-glaucoma drugs and complications, and lack of relevant indicators that directly reflect postoperative intraocular environment changes. The purpose of this study was to reveal the changes of cytokines in aqueous humor after UCP in patients with primary glaucoma, to analyze the possible causes of these factors, and to speculate the effect of their interaction on the surgical effect, in order to increase the predictability of UCP procedure.


Eligibility criteria: Inclusion Criteria:

* The patient was definitely diagnosed as glaucoma, No age or gender limitation, IOP(intraocular pressure) ≥ 21mmHg under the maximum tolerated dose of antiglaucoma medication, or IOP \< 21mmHg and glaucomatous optic nerve damage progressed.

Exclusion Criteria:

* Other eye diseases that could affect IOP; preoperative use of systemic steroid drugs; history of other anti-glaucoma surgery within 3 months; ocular infection 2 weeks prior to UCP

Primary outcomes:
measure: Cytokine profiles(pg/ml)
timeFrame: through study completion, an average of 2 year
measure: Intraocular pressure(mmHg)
timeFrame: through study completion, an average of 2 year
measure: Anterior segment parameters(mm)
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: LogMAR visual acuity
timeFrame: through study completion, an average of 2 year
measure: Complications(n,%)
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Chengguo Zuo, M.D,Ph.D
role: STUDY_DIRECTOR
References: