Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

EyeTechCare

Status: Completed

Conditions: Glaucoma

Treatments: Device: EyeOP1 device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02789293

ETC-EU-BN02

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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...)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Focused Ultrasound treatment

Experimental group

Description:

Ultrasound ciliary pasty (UCP) using focused ultrasound

Treatment:

Device: EyeOP1 device