Actively Recruiting
Comparison of Cytokines Profile in Aqueous Humor and Tear Before and After Ultrasound Cyclo Plasty Treatment for Glaucoma
Led by Zhongshan Ophthalmic Center, Sun Yat-sen University · Updated on 2024-02-06
200
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Glaucoma is a leading cause of irreversible vision loss in people aged 50 years and older worldwide, second only to cataracts. Researchers are studying Ultrasound Cyclo Plasty (UCP), a minimally invasive technique targeting the ciliary body to regulate intraocular pressure (IOP). This study aims to analyze changes in cytokines in the eye's aqueous humor after UCP to better understand their role in surgery outcomes and improve predictability of the procedure's success in patients with primary glaucoma. The treatment involves the use of the EyeOP1 device to perform UCP. During the procedure, a coupling cone is placed on the eye, secured with vacuum suction, and filled with balanced salt solution for ultrasound transmission. Ultrasound transducers emit energy at 21 MHz with controlled power and timing to target the ciliary body precisely. The study observes matched eyes of glaucoma patients before and after treatment to compare cytokine profiles and other eye parameters. Participants will be monitored over an average of two years, during which researchers will measure cytokine levels in aqueous humor, intraocular pressure, and anterior segment parameters. Additional evaluations include visual acuity and recording any complications. The study collects tear samples for follow-up, and data on the eye's environment changes post-treatment to assess the surgery's effects and safety over time.
CONDITIONS
Brief Title
Comparison of Cytokines Profile in Aqueous Humor and Tear Before and After UCP Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with glaucoma
- No age or gender restrictions
- Intraocular pressure (IOP) ≥ 21 mmHg while on maximum anti-glaucoma medication, or IOP < 21 mmHg with progressive optic nerve damage
- Requires Ultrasound Cyclo Plasty treatment
You will not qualify if you...
- Presence of other eye diseases affecting intraocular pressure
- Use of systemic steroid drugs before surgery
- History of anti-glaucoma surgery within the past 3 months
- Eye infection within 2 weeks before Ultrasound Cyclo Plasty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - One-time procedure with immediate treatment period
Participants receive Ultrasound CycloPlasty treatment for glaucoma using the EyeOP1 device.
1 treatment visit (in-person)
Duration - Approximately 2 years
Participants are monitored for cytokine profiles, intraocular pressure, anterior segment parameters, visual acuity, and complications after treatment.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
HuanYang Shi, M.D
C
Chengguo Zuo, M.D,Ph.D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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