GlaucomaNCT04321122
UCP (Ultrasound Cyclo Plasty) in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
A study testing ultrasound cyclo plasty in people with Glaucoma and Glaucoma, Primary Open Angle, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
Traditional ciliary body photocoagulation treatment uses the photocoagulation of long-wavelength laser to destroy the ciliary body tissue that can produce aqueous humor. Therefore, it is a kind of palliative treatment which has proved efficacy but causes great pain to patients. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Glaucoma, Primary Open Angle
- What is being tested?
- ultrasound cyclo plasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2018to 12 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The target eye was diagnosed as primary open-angle glaucoma; diagnostic criteria: IOP(intraocular pressure)≥ 21, open angle, typical glaucoma visual field and optic disc damage;
- Patients treated with glaucoma medications cannot control intraocular pressure effectively;
- Patients with 21mmHg ≤ IOP ≤ 30mmHg;
- VA(visual acuity)≥HM(hand motions);
- Patients that have failed conventional glaucoma surgery (trabeculectomy) or are not suitable for surgery;
- Patients who have not received intraocular surgery or laser treatment 90 days before receiving HIFU;
- Aged from 18 to 90 years old;
- Sign informed consent and be willing to provide visit data;
Who cannot join
- Either eye have any infections two weeks before the surgery;
- The target eye has history of ciliary surgery, intraocular or retrobulbar tumor;
- The target eye is neovascular glaucoma;
- The target eye is aphakic eye;
- Anterior anatomical abnormalities cause scleral expansion or ciliary body ectopic;
- Non-glaucoma intraocular diseases that affect intraocular pressure;
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- Within 30 days, the patient participated in or was simultaneously included in other clinical trials;
- Patients during pregnancy or lactation;
- Any systemic disease that may affect patient follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Weixin Zheng, M.D, 02066615461, zhengweixin@gzzoc.com
Chengguo Zuo, M.D,Ph.D, 02066615461, chengguozuo@163.com
About this study
Official title: Observation on the Clinical Safety and Efficacy of UCP (Ultrasound Cyclo Plasty) in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
Traditional ciliary body photocoagulation treatment uses the photocoagulation of long-wavelength laser to destroy the ciliary body tissue that can produce aqueous humor. Therefore, it is a kind of palliative treatment which has proved efficacy but causes great pain to patients. The "ultrasonic glaucoma treatment instrument" produced by French EYE TECH CARE company is referred to as EyeOP1. It uses high-intensity focused ultrasound technique to make target part of the ciliary coagulative necrosis, reduce the production of aqueous humor and thereby lower the intraocular pressure. EyeOP1 is ergonomic and suitable for the human eye, making the treatment process more accurate, simple and fast.
Read the detailed description
- Efficacy: 1. Main objective: (1)Assess the decrease in postoperative intraocular pressure from baseline and evaluate the final results (the percentage of patients whose conditions have significant improved and the variation of the percentage of median intraocular pressure. (2)Assess the amount of medication after surgery.
- Secondary goals:(1) Compare median intraocular pressure with baseline at each postoperative follow-up and access the variation of median intraocular pressure from baseline at each postoperative follow-up. (2) Count the number of intraocular pressure lowering drugs at each postoperative follow-up. b.Safety: Investigate the incidence of all device-related(or procedure-related) adverse events during the study (intraoperative and postoperative follow-up).
- Conditions
- Glaucoma, Glaucoma, Primary Open Angle
- Being tested
- ultrasound cyclo plasty
- Keywords
- Primary open-angle glaucoma, UCP(ultrasound cyclo plasty), Efficacy and Safety
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound cyclo plastyProcedure or surgery
Also called UCP
The "ultrasonic glaucoma treatment instrument" produced by French EYE TECH CARE company is referred to as EyeOP1.It uses high-intensity focused ultrasound technique to make target part of the ciliary coagulative necrosis, reduce the production of aqueous humor and thereby lower the intraocular pressure. EyeOP1 is ergonomic and suitable for the human eye, making the treatment process more accurate, simple and fast.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound cyclo plasty(UCP) | Experimental | Ultrasound cyclo plasty treatment for primary open-angle glaucoma patients. Receives: Procedure: ultrasound cyclo plasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP(intraocular pressure)
To evaluate the success rate of IOP control at 6 months after UCP(5mmHg≤IOP≤21mmHg, and at least 20% lower than the baseline)
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start12 Aug 2018
- Primary completion12 Mar 2020
- Study completion12 Jun 2020 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Ge, M.D,Ph.D, Study chair, Zhognshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321122
- Sponsor's protocol ID
- 2018QXPJ005
- Status last verified
- Jun 2019
- First submitted
- 23 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The archived documents and materials are not loaned. If the management department needs to access the original data, it should be agreed by the PI of the project.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation on the Clinical Safety and Efficacy of UCP (Ultrasound Cyclo Plasty) in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT04321122
- Acronym / sponsor ID
- 2018QXPJ005
- Conditions
- Glaucoma, Glaucoma, Primary Open Angle
- Keywords
- Primary open-angle glaucoma, UCP(ultrasound cyclo plasty), Efficacy and Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 12 Aug 2018 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Jun 2020 (estimated)
- First posted
- 25 Mar 2020 (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.
Traditional ciliary body photocoagulation treatment uses the photocoagulation of long-wavelength laser to destroy the ciliary body tissue that can produce aqueous humor. Therefore, it is a kind of palliative treatment which has proved efficacy but causes great pain to patients. The "ultrasonic glaucoma treatment instrument" produced by French EYE TECH CARE company is referred to as EyeOP1. It uses high-intensity focused ultrasound technique to make target part of the ciliary coagulative necrosis, reduce the production of aqueous humor and thereby lower the intraocular pressure. EyeOP1 is ergonomic and suitable for the human eye, making the treatment process more accurate, simple and fast.
Detailed description
- Efficacy: 1. Main objective: (1)Assess the decrease in postoperative intraocular pressure from baseline and evaluate the final results (the percentage of patients whose conditions have significant improved and the variation of the percentage of median intraocular pressure. (2)Assess the amount of medication after surgery.
- Secondary goals:(1) Compare median intraocular pressure with baseline at each postoperative follow-up and access the variation of median intraocular pressure from baseline at each postoperative follow-up. (2) Count the number of intraocular pressure lowering drugs at each postoperative follow-up. b.Safety: Investigate the incidence of all device-related(or procedure-related) adverse events during the study (intraoperative and postoperative follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound cyclo plasty(UCP) | Experimental | Procedure: ultrasound cyclo plastyUltrasound cyclo plasty treatment for primary open-angle glaucoma patients. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The target eye was diagnosed as primary open-angle glaucoma; diagnostic criteria: IOP(intraocular pressure)≥ 21, open angle, typical glaucoma visual field and optic disc damage;
- Patients treated with glaucoma medications cannot control intraocular pressure effectively;
- Patients with 21mmHg ≤ IOP ≤ 30mmHg;
- VA(visual acuity)≥HM(hand motions);
- Patients that have failed conventional glaucoma surgery (trabeculectomy) or are not suitable for surgery;
Key exclusion criteria (9 listed)
- Either eye have any infections two weeks before the surgery;
- The target eye has history of ciliary surgery, intraocular or retrobulbar tumor;
- The target eye is neovascular glaucoma;
- The target eye is aphakic eye;
- Anterior anatomical abnormalities cause scleral expansion or ciliary body ectopic;
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 cyclo plastyAlso: UCPThe "ultrasonic glaucoma treatment instrument" produced by French EYE TECH CARE company is referred to as EyeOP1.It uses high-intensity focused ultrasound technique to make target part of the ciliary coagulative necrosis, reduce the production of aqueous humor and thereby lower the intraocular pressure. EyeOP1 is ergonomic and suitable for the human eye, making the treatment process more accurate, simple and fast. | Procedure or surgery | Ultrasound cyclo plasty(UCP) |
Primary outcome
IOP(intraocular pressure)
Time frame: 6 months after surgery
To evaluate the success rate of IOP control at 6 months after UCP(5mmHg≤IOP≤21mmHg, and at least 20% lower than the baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No. The archived documents and materials are not loaned. If the management department needs to access the original data, it should be agreed by the PI of the project.
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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. This study is not recruiting at the moment.
Jian Ge, M.D,Ph.D study chair
Zhognshan 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?
A study testing ultrasound cyclo plasty in people with Glaucoma and Glaucoma, Primary Open Angle, 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengguo Zuo, M.D,Ph.D (: 020-66615461, chengguozuo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP(intraocular pressure) (time frame: 6 months after surgery). 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 25 Mar 2020.