Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06243497

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Glaucoma Aqueous Humor Cytokines Eye Diseases Lacerations Ocular Hypertension Tear Ultrasound Cyclo Plasty Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cytokine profiles(pg/ml)

    Time frame: through study completion, an average of 2 year

    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.

  2. Intraocular pressure(mmHg)

    Time frame: through study completion, an average of 2 year

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

  3. Anterior segment parameters(mm)

    Time frame: through study completion, an average of 2 year

    Measured by ultrasound biomicroscopy, parameters included WTW, ciliary body length, ciliary process length and density.

Secondary outcomes

  1. LogMAR visual acuity

    Time frame: through study completion, an average of 2 year

    Using Snellen visual acuity chart to measure naked eye vision and best corrected vision

  2. Complications(n,%)

    Time frame: through study completion, an average of 2 year

    Including conjunctival congestion, corneal edema, corneal epithelial defect, anterior chamber inflammation, pupil deformation,cataract development/progression, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Chengguo Zuo, M.D,Ph.D

CONTACT

[email protected]

+8602066615461 ext. 02066615461

HuanYang Shi, M.D

CONTACT

[email protected]

+8602066615461 ext. 02066615461

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2024
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.