Clinical trial NCT04145830: 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
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma Treatment Using Focused Ultrasound
Keywords: Glaucoma, ciliary body, ultrasound
Lead sponsor: EyeTechCare
Sponsor class: INDUSTRY
First posted: 2019-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Efficacy endpoint : reduction of the intraocular pressure
timeFrame: 6 months
Secondary outcomes:
measure: Safety endpoint: rate of per operative complications
timeFrame: 6 months
measure: Safety endpoint: rate of post-operative complications
timeFrame: 6 months
measure: Efficacy endpoint: Number of ocular hypotensive medications
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Diseases Prevention and Treatment Center - Department of Ophthalmology
city: Shanghai
country: China
facility: E&ENT Fudan University
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.