Back to results

UCP Glaucoma Treatment for Primary Glaucoma in China

Primary Purpose

Glaucoma Treatment Using Focused Ultrasound

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Ultrasound Cyclo Plasty (UCP)

About this trial

This is an interventional treatment trial for Glaucoma Treatment Using Focused Ultrasound focused on measuring Glaucoma, ciliary body, ultrasound

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasound Cyclo Plasty (UCP)

Arm Description

Ultrasound Cyclo Plasty (UCP) using focused ultrasound

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety endpoint: rate of per operative complications

Rate of per-operative device and/or procedure related adverse events

Safety endpoint: rate of post-operative complications

Rate of post-operative complications during the follow-up period

Efficacy endpoint: Number of ocular hypotensive medications

Mean number of IOP lowering medications at each visit during the follow-up period

Full Information

NCT ID

NCT04145830

First Posted

October 29, 2019

Last Updated

August 18, 2021

Sponsor

EyeTechCare

1. Study Identification

Unique Protocol Identification Number

NCT04145830

Brief Title

UCP Glaucoma Treatment for Primary Glaucoma in China

Official Title

Efficacy and Safety of UCP in the Treatment of Primary Glaucoma in China

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

April 29, 2020 (Actual)

Study Completion Date

November 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EyeTechCare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma Treatment Using Focused Ultrasound

Keywords

Glaucoma, ciliary body, ultrasound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound Cyclo Plasty (UCP)

Arm Type

Experimental

Arm Description

Ultrasound Cyclo Plasty (UCP) using focused ultrasound

Intervention Type

Device

Intervention Name(s)

Ultrasound Cyclo Plasty (UCP)

Other Intervention Name(s)

UCP by EyeOP1 device

Intervention Description

Cyclocoagulation using High Intensity Focused Ultrasound

Primary Outcome Measure Information:

Title

Efficacy endpoint : reduction of the intraocular pressure

Description

Reduction of the intraocular pressure relative to the preoperative value at each follow-up visits in mmHg and in % of reduction

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Safety endpoint: rate of per operative complications

Description

Rate of per-operative device and/or procedure related adverse events

Time Frame

6 months

Title

Safety endpoint: rate of post-operative complications

Description

Rate of post-operative complications during the follow-up period

Time Frame

6 months

Title

Efficacy endpoint: Number of ocular hypotensive medications

Description

Mean number of IOP lowering medications at each visit during the follow-up period

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Facility Information:

Facility Name

Shanghai Eye Diseases Prevention and Treatment Center - Department of Ophthalmology

City

Shanghai

ZIP/Postal Code

2000040

Country

China

Facility Name

E&ENT Fudan University

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26547890

Citation

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.

Results Reference

background

PubMed Identifier

31024813

Citation

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.

Results Reference

background

PubMed Identifier

29043438

Citation

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.

Results Reference

background

PubMed Identifier

31125570

Citation

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.

Results Reference

background

PubMed Identifier

29768281

Citation

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.

Results Reference

background

PubMed Identifier

30809493

Citation

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.

Results Reference

background

PubMed Identifier

25982212

Citation

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.

Results Reference

background

Learn more about this trial

UCP Glaucoma Treatment for Primary Glaucoma in China

We'll reach out to this number within 24 hrs