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

NCT06243497 | Recruiting

• 1 other identifier: 2022KYPJ255
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Ultrasound Cyclo Plasty; Aqueous Humor; Tear; Cytokines

Outcome Measures

Primary Outcomes (3)

• 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

• Intraocular pressure(mmHg)

  Using non-contact tonometer (NCT) to measure intraocular pressure

  through study completion, an average of 2 year

• 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 Outcomes (2)

• LogMAR visual acuity

  through study completion, an average of 2 year

• Complications(n,%)

  through study completion, an average of 2 year

Study Arms (2)

Matched eyes

Patients with glaucoma matched by sex and age.

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.

Procedure: Ultrasound CycloPlasty

Interventions

Ultrasound CycloPlasty 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.

Treated eyes with UCP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatient sample

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Glaucoma; Lacerations

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Wounds and Injuries

Study Officials

• Chengguo Zuo, M.D,Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

HuanYang Shi, M.D

CONTACT

+8602066615461; shyhuanyang@163.com

Chengguo Zuo, M.D,Ph.D

CONTACT

+8602066615461; zuochengguo@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: February 6, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 6, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)