Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

Glaucoma Clinical Trial

Official title:

Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789293
• Other study ID #: ETC-EU-BN02
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 4, 2019

Study information

• Verified date: July 2019
• Source: EyeTechCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 4, 2019
• Est. primary completion date: October 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Open Angle Glaucoma patient (Primary Open Angle Glaucoma (POAG) including Pigmentary Glaucoma (PG) and PseudoExfoliative Glaucoma (PXF))
• Any patients without previous conventional glaucoma surgery failure (trabeculectomy, Deep Sclerectomy, Ahmed valve, drainage device implantation, cyclo cryotherapy, Diode laser cyclo-destruction)
• Subjects where the IOP is not adequately controlled with glaucoma medication, with IOP = 21 mm Hg and <30 mmHg
• No previous intraocular surgery or laser treatment during the 90 days before HIFU Day
• Age > 18 years and < 90 years
• Patient able and willing to complete postoperative follow-up requirements

Exclusion Criteria:

• Patient who has been diagnosed for normal tension glaucoma
• Ocular or retrobulbar tumor
• Ocular infection within 14 days prior to the HIFU procedure
• 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, clinically significant macular edema…)

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Device:
• EyeOP1 device
Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound

Locations

Country	Name	City	State
Belgium	UZ Leuven - University Hospital	Leuven
Israel	The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center	Tel Hashomer
Italy	Cisanello Hospital	Pisa
Portugal	Santa Maria Hospital - Faculty of Medicine of Lisbon	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
EyeTechCare

Countries where clinical trial is conducted

Belgium,  Israel,  Italy,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy endpoint : Reduction of intraocular pressure	Reduction of intraocular pressure at 24 months relative to the preoperative value assessed at each follow-up visits with the final measurement of success at 24 months	24 months
Secondary	Safety : rate of per and post-operative complications/adverse effects	rate of per-operative device and /or procedure related adverse events and post-operative complications at each follow-up visits	24 months
Secondary	Efficacy endpoint : Mean IOP (mmHg)	Evolution of the Mean IOP (mmHg) at each visit during the follow-up period (Baseline to 24 months)	24 months
Secondary	Efficacy Endpoint : Mean IOP variation (%)	Mean IOP variation (%) at each visit during the follow-up period	24 months
Secondary	Mean Number of ocular hypotensive medications	Mean number of ocular hypotensive medication at each visit during the followup period	24 months