Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-10-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Focused Ultrasound treatment

Ultrasound ciliary pasty (UCP) using focused ultrasound

Group Type EXPERIMENTAL

EyeOP1 device

Intervention Type DEVICE

Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound

Interventions

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EyeOP1 device

Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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…)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No