GlaucomaNCT06243497
Comparison of Cytokines Profile in Aqueous Humor and Tear Before and After UCP Treatment
An observational study of Glaucoma and Ultrasound Cyclo Plasty, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Ultrasound Cyclo Plasty, Aqueous Humor
- What is being tested?
- Ultrasound CycloPlasty
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatient sample
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Huanyang Shi, M.D, +8602066615461, shyhuanyang@163.com
Chengguo Zuo, M.D,Ph.D, +8602066615461, zuochengguo@mail.sysu.edu.cn
About this study
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
- Being tested
- Ultrasound CycloPlasty
- Medical subject headings
- Glaucoma, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound CycloPlastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ultrasound CycloPlasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 year
Intraocular pressure(mmHg)
Using non-contact tonometer (NCT) to measure intraocular pressure
Measured: 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.
Measured: through study completion, an average of 2 year
Secondary outcomes (2)
LogMAR visual acuity
Using Snellen visual acuity chart to measure naked eye vision and best corrected vision
Measured: through study completion, an average of 2 year
Complications(n,%)
Including conjunctival congestion, corneal edema, corneal epithelial defect, anterior chamber inflammation, pupil deformation,cataract development/progression, etc.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chengguo Zuo, M.D,Ph.D, Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243497
- Sponsor's protocol ID
- 2022KYPJ255
- Status last verified
- May 2023
- First submitted
- 26 Sep 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cytokines Profile in Aqueous Humor and Tear Before and After UCP Treatment
- ClinicalTrials.gov ID
- NCT06243497
- Acronym / sponsor ID
- 2022KYPJ255
- Conditions
- Glaucoma, Ultrasound Cyclo Plasty, Aqueous Humor, Tear, Cytokines
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matched eyes | – | –Patients with glaucoma matched by sex and age. |
| Treated eyes with UCP | – | Procedure: Ultrasound CycloPlastyThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatient sample
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound CycloPlastyAll 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. | Procedure or surgery | Treated eyes with UCP |
Primary outcome
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.
Intraocular pressure(mmHg)
Time frame: through study completion, an average of 2 year
Using non-contact tonometer (NCT) to measure intraocular pressure
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.
2 secondary outcomes
LogMAR visual acuity
Time frame: through study completion, an average of 2 year
Complications(n,%)
Time frame: through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chengguo Zuo, M.D,Ph.D study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Ultrasound Cyclo Plasty, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HuanYang Shi, M.D (+8602066615461 ext. 02066615461, shyhuanyang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine profiles(pg/ml) (time frame: through study completion, an average of 2 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.