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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2027-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma Ultrasound Cyclo Plasty Aqueous Humor Tear Cytokines

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Matched eyes

Patients with glaucoma matched by sex and age.

No interventions assigned to this group

Treated eyes with UCP

The patients were 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. UCP treatment is required for the patients.

Ultrasound CycloPlasty

Intervention Type PROCEDURE

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.

Interventions

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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 sector and a 20-s pause between each treatment to allow complete evacuation of heat.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No