Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device

Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound (HIFU). A Prospective, Multicenter, Open-label, Safety and Efficacy Study of the Treatment With the EYEOP Medical Device in Patients With Refractory Glaucoma

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01338467

Enrollment

Registered

2011-04-19

Start date

2011-04-30

Completion date

2013-11-30

Last updated

2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

Glaucoma, Refractory glaucoma, Cyclocoagulation, High Intensity Focused Ultrasound

Brief summary

The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.

Interventions

DEVICEEYEOP device

Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Primary open angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma in the study eye with maximally tolerated medical treatment * Ocular hypertension defined as an intraocular pressure (IOP) \> 21 mm Hg * Subject has failed a conventional intraocular glaucoma filtering surgery * Patient must be aged 18 years or more * No previous intraocular glaucoma surgery or laser treatment in the study eye during the 3 months before HIFU treatment * No previous cyclophotocoagulation procedure in the study eye * Patient able and willing to provide informed consent and to complete post-operative follow-up requirements.

Exclusion criteria

* History of previous glaucoma surgery with implantation of glaucoma drainage device in the study eye * History of ocular or retrobulbar tumor * Retinal detachment, choroidal hemorrhage or detachment * Ocular infectious disease within 14 days before HIFU treatment

Design outcomes

Primary

Measure	Time frame	Description
Primary efficacy measure :	6 months	IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment

Secondary

Measure	Time frame	Description
Safety measures	6 months	The incidence of device and procedure-related complications during the follow-up

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026