UCP Glaucoma Treatment for Primary Glaucoma in China

NCT04145830 | Completed

• 1 other identifier: CS18-CHN-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Glaucoma Treatment Using Focused Ultrasound

Keywords

Glaucoma, ciliary body, ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (3)

• Safety endpoint: rate of per operative complications

  6 months

• Safety endpoint: rate of post-operative complications

  6 months

• Efficacy endpoint: Number of ocular hypotensive medications

  6 months

Study Arms (1)

Ultrasound Cyclo Plasty (UCP)

EXPERIMENTAL

Ultrasound Cyclo Plasty (UCP) using focused ultrasound

Device: Ultrasound Cyclo Plasty (UCP)

Interventions

Ultrasound Cyclo Plasty (UCP) DEVICE

Cyclocoagulation using High Intensity Focused Ultrasound

Also known as: UCP by EyeOP1 device

Ultrasound Cyclo Plasty (UCP)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• EyeTechCare: lead

Study Sites (2)

Shanghai Eye Diseases Prevention and Treatment Center - Department of Ophthalmology

Shanghai, 2000040, China

Location

E&ENT Fudan University

Shanghai, China

Location

Related Publications (7)

• 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.

  PMID: 26547890 BACKGROUND

• 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.

  PMID: 31024813 BACKGROUND

• 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.

  PMID: 29043438 BACKGROUND

• 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.

  PMID: 31125570 BACKGROUND

• 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.

  PMID: 29768281 BACKGROUND

• 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.

  PMID: 30809493 BACKGROUND

• 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.

  PMID: 25982212 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: September 1, 2019
• Primary Completion: April 29, 2020
• Study Completion: November 2, 2020
• Last Updated: August 19, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)