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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243497
• Other study ID #: 2022KYPJ255
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: May 2023
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: HuanYang Shi, M.D
• Phone: +8602066615461
• Email: shyhuanyang[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cytokines
• Glaucoma
• Tear

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine profiles(pg/ml)	Cytokine antibody array was used to detect cytokines in AH samples from UCP treatment group and control group. The analysis method is based on the principle of double antibody sandwich immunoassay, and 60 ul of samples are applied on each block. Antibodies against the selected cytokines were immobilized at specific locations on the chip surface. The cytokines in the sample were captured by the corresponding antibody, and a mixture of biotinylated antibodies was added to detect the binding cytokines. Finally, the signal was visualized using a fluorescent dye ( cy3 equivalent ) that binds to streptavidin. The InnoScan 300 Microarray Scanner ( Innopsys, Parc d 'Activités Activestre, Carbonne, France ) was used for fluorescent dye detection.	through study completion, an average of 2 year
Primary	Intraocular pressure(mmHg)	Using non-contact tonometer (NCT) to measure intraocular pressure	through study completion, an average of 2 year
Primary	Anterior segment parameters(mm)	Measured by ultrasound biomicroscopy, parameters included WTW, ciliary body length, ciliary process length and density.	through study completion, an average of 2 year
Secondary	LogMAR visual acuity	Using Snellen visual acuity chart to measure naked eye vision and best corrected vision	through study completion, an average of 2 year
Secondary	Complications(n,%)	Including conjunctival congestion, corneal edema, corneal epithelial defect, anterior chamber inflammation, pupil deformation,cataract development/progression, etc.	through study completion, an average of 2 year