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

Обзор

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.

Вмешательства

• Процедура Ultrasound 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

Первичные конечные точки

• Cytokine profiles(pg/ml) [Срок оценки: through study completion, an average of 2 year]
• Intraocular pressure(mmHg) [Срок оценки: through study completion, an average of 2 year]
• Anterior segment parameters(mm) [Срок оценки: through study completion, an average of 2 year]

Вторичные конечные точки (2)

• LogMAR visual acuity [Срок оценки: through study completion, an average of 2 year]
• Complications(n,%) [Срок оценки: through study completion, an average of 2 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Zhognshan Ophthalmic Center, Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT06243497 · 2022KYPJ255

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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