Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU)

Glaucoma Clinical Trial

Official title:

Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound With the EyeOP1 Medical Device.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592955
• Other study ID #: EYEMUST-2
• Status: Completed
• Phase: Phase 4
• First received: May 4, 2012
• Last updated: June 15, 2015
• Start date: May 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2013
• Source: EyeTechCare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel : Ministry Of Health (MOH)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Refractory Glaucoma

• IOP > 21 mm Hg

• No previous intraocular surgery or laser treatment during the 90 days before HIFU day

• Age > 18 years

• Informed consent sgned by the subject

Exclusion Criteria:

• Normal Tension Glaucoma

• Glaucoma drainage device implanted and still present in the eye to be treated

• History of ocular or retrobulbar tumor

• Ocular infection within 14 days prior to the HIFU procedure

• Aphakic patient

• Ocular disease other than glaucoma that may affect assessment of visual and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema)

• Pregnant or breast-feeding women, or lack of contraception use among women likely to have a child

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• EYEOP1
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device

Locations

Country	Name	City	State
Israel	The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center	Tel Hashomer
Italy	Ospedale San Paolo	Milano
Italy	Institute Ophthalmology - Universita di Parma	Parma
Italy	Clinica Oculistica Universitaria - P-O Oftalmico	Torino
Spain	Hospital Clinico San Carlos	Madrid
Switzerland	Hôpitaux Universitaires de Genève	Genève
Switzerland	Clinique de Montchoisi - Glaucoma center	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
EyeTechCare

Countries where clinical trial is conducted

Israel,  Italy,  Spain,  Switzerland, 

References & Publications (1)

Melamed S, Goldenfeld M, Cotlear D, Skaat A, Moroz I. High-intensity focused ultrasound treatment in refractory glaucoma patients: results at 1 year of prospective clinical study. Eur J Ophthalmol. 2015 Nov-Dec;25(6):483-9. doi: 10.5301/ejo.5000620. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy endpoint : Success / failure rate at 1 year	IOP change (mm Hg and percent) from baseline to 12 months post-HIFU treatment. (Success defined by IOP reduction > 20% compared to the baseline IOP or IOP < 21 mmHg)	12 months	No
Secondary	Safety measures	Number of device and procedure-related and others complications during follow-up	12 months	Yes