Glaucoma Treatment Using Focused UltrasoundNCT04145830

UCP Glaucoma Treatment for Primary Glaucoma in China

A study testing Ultrasound Cyclo Plasty (UCP) in people with Glaucoma Treatment Using Focused Ultrasound, run by EyeTechCare at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To collect safety and efficacy data on Ultrasound Cycle Plasty treatment (UCP) in primary glaucoma asian patients. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Glaucoma Treatment Using Focused Ultrasound
What is being tested?: Ultrasound Cyclo Plasty (UCP)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesChina
Study dates: 1 Sep 2019to 2 Nov 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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Primary Open Angle and primary Angle Closure glaucoma
Subject where the IOP is not adequately controlled with glaucoma medication, and can not or not agree for incisional glaucoma surgery
IOP ≥ 21 mmHg and ≤ 40 mmHg
Best Corrected Visual Acuity > Hand Motion
Patient able and willing to sign the informed consent and complete postoperative followup requirements

Who cannot join

History of ocular or retrobulbar tumor
Ocular infection within 14 days prior to the procedure of Ultrasound Cyclo Plasty (UCP)
History of Cyclo-destructive procedures (cryotherapy, Laser transscleral cyclophotocoagulation; Laser endophotocoagulation)
Congenital glaucoma
History of ciliary body surgery or vitrectomy in the study eye
Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema, retinal detachment)

Trial locations and contacts

2 sites in 1 country.

China2 sites

Shanghai Eye Diseases Prevention and Treatment Center - Department of Ophthalmology
Shanghai, 2000040
E&ENT Fudan University
Shanghai

Other trials in China

About this study

Official title: Efficacy and Safety of UCP in the Treatment of Primary Glaucoma in China

To collect safety and efficacy data on Ultrasound Cycle Plasty treatment (UCP) in primary glaucoma asian patients.

Conditions: Glaucoma Treatment Using Focused Ultrasound
Being tested: Ultrasound Cyclo Plasty (UCP)
Keywords: Glaucoma, ciliary body, ultrasound
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ultrasound Cyclo Plasty (UCP)Device
Also called UCP by EyeOP1 device
Cyclocoagulation using High Intensity Focused Ultrasound

Study groups in NCT04145830
Study group	Role	What they receive
Ultrasound Cyclo Plasty (UCP)	Experimental	Ultrasound Cyclo Plasty (UCP) using focused ultrasound Receives: Device: Ultrasound Cyclo Plasty (UCP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy endpoint : reduction of the intraocular pressure
Reduction of the intraocular pressure relative to the preoperative value at each follow-up visits in mmHg and in % of reduction
Measured: 6 months

Secondary outcomes (3)

Safety endpoint: rate of per operative complications
Rate of per-operative device and/or procedure related adverse events
Measured: 6 months
Safety endpoint: rate of post-operative complications
Rate of post-operative complications during the follow-up period
Measured: 6 months
Efficacy endpoint: Number of ocular hypotensive medications
Mean number of IOP lowering medications at each visit during the follow-up period
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20192 Nov 2020

First posted31 Oct 2019
Study start1 Sep 2019
Primary completion29 Apr 2020
Study completion2 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Glaucoma Treatment Using Focused UltrasoundStudies of the same condition, open and under way.
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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04145830
Sponsor's protocol ID: CS18-CHN-04
Status last verified: Oct 2019
First submitted: 29 Oct 2019
Last updated: 19 Aug 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Aptel F, Denis P, Rouland JF, Renard JP, Bron A. Multicenter clinical trial of high-intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery. Acta Ophthalmol. 2016 Aug;94(5):e268-77. doi: 10.1111/aos.12913. Epub 2015 Nov 7.
PubMed 26547890
Torky MA, Al Zafiri YA, Hagras SM, Khattab AM, Bassiouny RM, Mokbel TH. Safety and efficacy of ultrasound ciliary plasty as a primary intervention in glaucoma patients. Int J Ophthalmol. 2019 Apr 18;12(4):597-602. doi: 10.18240/ijo.2019.04.12. eCollection 2019.
PubMed 31024813
De Gregorio A, Pedrotti E, Stevan G, Montali M, Morselli S. Safety and efficacy of multiple cyclocoagulation of ciliary bodies by high-intensity focused ultrasound in patients with glaucoma. Graefes Arch Clin Exp Ophthalmol. 2017 Dec;255(12):2429-2435. doi: 10.1007/s00417-017-3817-4. Epub 2017 Oct 17.
PubMed 29043438
Posarelli C, Covello G, Bendinelli A, Fogagnolo P, Nardi M, Figus M. High-intensity focused ultrasound procedure: The rise of a new noninvasive glaucoma procedure and its possible future applications. Surv Ophthalmol. 2019 Nov-Dec;64(6):826-834. doi: 10.1016/j.survophthal.2019.05.001. Epub 2019 May 22.
PubMed 31125570
Giannaccare G, Vagge A, Sebastiani S, Urbini LE, Corazza P, Pellegrini M, Carmassi L, Bergamini F, Traverso CE, Campos EC. Ultrasound Cyclo-Plasty in Patients with Glaucoma: 1-Year Results from a Multicentre Prospective Study. Ophthalmic Res. 2019;61(3):137-142. doi: 10.1159/000487953. Epub 2018 May 16.
PubMed 29768281
Pellegrini M, Sebastiani S, Giannaccare G, Campos EC. Intraocular inflammation after Ultrasound Cyclo Plasty for the treatment of glaucoma. Int J Ophthalmol. 2019 Feb 18;12(2):338-341. doi: 10.18240/ijo.2019.02.23. eCollection 2019.
PubMed 30809493
Melamed S, Goldenfeld M, Cotlear D, Skaat A, Moroz I. High-intensity focused ultrasound treatment in refractory glaucoma patients: results at 1 year of prospective clinical study. Eur J Ophthalmol. 2015 Nov-Dec;25(6):483-9. doi: 10.5301/ejo.5000620. Epub 2015 May 13.
PubMed 25982212

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of UCP in the Treatment of Primary Glaucoma in China
ClinicalTrials.gov ID: NCT04145830
Acronym / sponsor ID: CS18-CHN-04
Conditions: Glaucoma Treatment Using Focused Ultrasound
Keywords: Glaucoma, ciliary body, ultrasound
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: EyeTechCareIndustry (pharma, biotech, devices)
Study start: 1 Sep 2019 (actual)
Primary completion: 29 Apr 2020 (actual)
Study completion: 2 Nov 2020 (actual)
First posted: 31 Oct 2019 (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.

To collect safety and efficacy data on Ultrasound Cycle Plasty treatment (UCP) in primary glaucoma asian patients.

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	Device: Ultrasound Cyclo Plasty (UCP)Ultrasound Cyclo Plasty (UCP) using focused ultrasound

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Primary Open Angle and primary Angle Closure glaucoma
Subject where the IOP is not adequately controlled with glaucoma medication, and can not or not agree for incisional glaucoma surgery
IOP ≥ 21 mmHg and ≤ 40 mmHg
Best Corrected Visual Acuity > Hand Motion
Patient able and willing to sign the informed consent and complete postoperative followup requirements

Key exclusion criteria (6 listed)

History of ocular or retrobulbar tumor
Ocular infection within 14 days prior to the procedure of Ultrasound Cyclo Plasty (UCP)
History of Cyclo-destructive procedures (cryotherapy, Laser transscleral cyclophotocoagulation; Laser endophotocoagulation)
Congenital glaucoma
History of ciliary body surgery or vitrectomy in the study eye

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 Plasty (UCP)Also: UCP by EyeOP1 deviceCyclocoagulation using High Intensity Focused Ultrasound	Device	Ultrasound Cyclo Plasty (UCP)

Primary outcome

Efficacy endpoint : reduction of the intraocular pressure
Time frame: 6 months
Reduction of the intraocular pressure relative to the preoperative value at each follow-up visits in mmHg and in % of reduction

3 secondary outcomes

Safety endpoint: rate of per operative complications
Time frame: 6 months
Safety endpoint: rate of post-operative complications
Time frame: 6 months
Efficacy endpoint: Number of ocular hypotensive medications
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
Background: PubMed 26547890Aptel F, Denis P, Rouland JF, Renard JP, Bron A. Multicenter clinical trial of high-intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery. Acta Ophthalmol. 2016 Aug;94(5):e268-77. doi: 10.1111/aos.12913. Epub 2015 Nov 7.
Background: PubMed 31024813Torky MA, Al Zafiri YA, Hagras SM, Khattab AM, Bassiouny RM, Mokbel TH. Safety and efficacy of ultrasound ciliary plasty as a primary intervention in glaucoma patients. Int J Ophthalmol. 2019 Apr 18;12(4):597-602. doi: 10.18240/ijo.2019.04.12. eCollection 2019.
Background: PubMed 29043438De Gregorio A, Pedrotti E, Stevan G, Montali M, Morselli S. Safety and efficacy of multiple cyclocoagulation of ciliary bodies by high-intensity focused ultrasound in patients with glaucoma. Graefes Arch Clin Exp Ophthalmol. 2017 Dec;255(12):2429-2435. doi: 10.1007/s00417-017-3817-4. Epub 2017 Oct 17.
Background: PubMed 31125570Posarelli C, Covello G, Bendinelli A, Fogagnolo P, Nardi M, Figus M. High-intensity focused ultrasound procedure: The rise of a new noninvasive glaucoma procedure and its possible future applications. Surv Ophthalmol. 2019 Nov-Dec;64(6):826-834. doi: 10.1016/j.survophthal.2019.05.001. Epub 2019 May 22.
Background: PubMed 29768281Giannaccare G, Vagge A, Sebastiani S, Urbini LE, Corazza P, Pellegrini M, Carmassi L, Bergamini F, Traverso CE, Campos EC. Ultrasound Cyclo-Plasty in Patients with Glaucoma: 1-Year Results from a Multicentre Prospective Study. Ophthalmic Res. 2019;61(3):137-142. doi: 10.1159/000487953. Epub 2018 May 16.
Background: PubMed 30809493Pellegrini M, Sebastiani S, Giannaccare G, Campos EC. Intraocular inflammation after Ultrasound Cyclo Plasty for the treatment of glaucoma. Int J Ophthalmol. 2019 Feb 18;12(2):338-341. doi: 10.18240/ijo.2019.02.23. eCollection 2019.
Background: PubMed 25982212Melamed S, Goldenfeld M, Cotlear D, Skaat A, Moroz I. High-intensity focused ultrasound treatment in refractory glaucoma patients: results at 1 year of prospective clinical study. Eur J Ophthalmol. 2015 Nov-Dec;25(6):483-9. doi: 10.5301/ejo.5000620. Epub 2015 May 13.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites 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 (UCP) in people with Glaucoma Treatment Using Focused Ultrasound, run by EyeTechCare at 2 sites 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy endpoint : reduction of the intraocular pressure (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04145830, which also lists 7 linked publications.

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 19 Aug 2021.