RecruitingNCT06243497

Comparison of Cytokines Profile in Aqueous Humor and Tear Before and After UCP Treatment


Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Enrollment

200 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a procedure called ultrasound cyclophotocoagulation (UCP) — a non-invasive treatment for glaucoma that uses focused ultrasound to reduce eye pressure — changes certain proteins (called cytokines) in the fluid inside the eye and in tears. The goal is to better understand how this glaucoma treatment works at a molecular level. **You may be eligible if...** - You have been definitively diagnosed with glaucoma - Your eye pressure is above 21 mmHg even on the maximum tolerated dose of glaucoma eye drops, OR your eye pressure is lower but your optic nerve damage is still getting worse - There is no age or gender restriction **You may NOT be eligible if...** - You have other eye diseases that could independently affect eye pressure - You are taking systemic (oral or injected) steroid medications - You have had other glaucoma surgery within the past 3 months - You have had an eye infection in the past 2 weeks Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUltrasound CycloPlasty

All procedures were performed using the EyeOP1 device . The coupling cone was placed and adjusted on the centre of the patient's eye by visualising an equal white scleral ring surrounding the cornea. The coupling cone was kept in place via vacuum suction activated using a foot pedal and was then filled with a balanced salt solution to allow ultrasound transmission. The transducers were automatically activated at a frequency of 21 MHz and an acoustic power of 2.45 W, with an 8-s duration for each sector and a 20-s pause between each treatment to allow complete evacuation of heat.


Locations(1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06243497


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