Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: EyeOP1 device

• Registration Number: NCT02789293
• Lead Sponsor: EyeTechCare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-02
• Primary Completion: 2017-10-12
• Status Verified: 2019-07
• Study Completion: 2019-10-04
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Focused Ultrasound treatment	EyeOP1 device	Ultrasound ciliary pasty (UCP) using focused ultrasound

Primary Outcome Measures

Name	Time	Method
Efficacy endpoint : Reduction of intraocular pressure	24 months	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

Secondary Outcome Measures

Name	Time	Method
Efficacy Endpoint : Mean IOP variation (%)	24 months	Mean IOP variation (%) at each visit during the follow-up period
Safety : rate of per and post-operative complications/adverse effects	24 months	rate of per-operative device and /or procedure related adverse events and post-operative complications at each follow-up visits
Efficacy endpoint : Mean IOP (mmHg)	24 months	Evolution of the Mean IOP (mmHg) at each visit during the follow-up period (Baseline to 24 months)
Mean Number of ocular hypotensive medications	24 months	Mean number of ocular hypotensive medication at each visit during the followup period

Trial Locations

Locations (4)

UZ Leuven - University Hospital; 🇧🇪 Leuven, Belgium

The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

Cisanello Hospital; 🇮🇹 Pisa, Italy

Santa Maria Hospital - Faculty of Medicine of Lisbon; 🇵🇹 Lisboa, Portugal