UCP Glaucoma Treatment for Primary Glaucoma in China

NCT ID: NCT04145830

Last Updated: 2021-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-11-02

Brief Summary

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

Detailed Description

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Conditions

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Glaucoma Treatment Using Focused Ultrasound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrasound Cyclo Plasty (UCP)

Ultrasound Cyclo Plasty (UCP) using focused ultrasound

Group Type EXPERIMENTAL

Ultrasound Cyclo Plasty (UCP)

Intervention Type DEVICE

Cyclocoagulation using High Intensity Focused Ultrasound

Interventions

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Ultrasound Cyclo Plasty (UCP)

Cyclocoagulation using High Intensity Focused Ultrasound

Intervention Type DEVICE

Other Intervention Names

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UCP by EyeOP1 device

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EyeTechCare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Eye Diseases Prevention and Treatment Center - Department of Ophthalmology

Shanghai, , China

Site Status

E&ENT Fudan University

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 26547890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31024813 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29043438 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31125570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29768281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30809493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25982212 (View on PubMed)

Other Identifiers

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CS18-CHN-04

Identifier Type: -

Identifier Source: org_study_id

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