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

Primary Purpose

Glaucoma

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

EYEOP1

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Cyclocoagulation, HIFU High Intensity Focused Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
Ospedale San Paolo
Institute Ophthalmology - Universita di Parma
Clinica Oculistica Universitaria - P-O Oftalmico
Hospital Clinico San Carlos
Hôpitaux Universitaires de Genève
Clinique de Montchoisi - Glaucoma center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EYEOP1 device

Arm Description

cyclocoagulation HIFU

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Safety measures

Number of device and procedure-related and others complications during follow-up

Full Information

NCT ID

NCT01592955

First Posted

May 4, 2012

Last Updated

June 15, 2015

Sponsor

EyeTechCare

1. Study Identification

Unique Protocol Identification Number

NCT01592955

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EyeTechCare

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Glaucoma, Cyclocoagulation, HIFU High Intensity Focused Ultrasound

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EYEOP1 device

Arm Type

Experimental

Arm Description

cyclocoagulation HIFU

Intervention Type

Device

Intervention Name(s)

EYEOP1

Intervention Description

Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device

Primary Outcome Measure Information:

Title

Efficacy endpoint : Success / failure rate at 1 year

Description

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)

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Safety measures

Description

Number of device and procedure-related and others complications during follow-up

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurent FARCY

Organizational Affiliation

EyeTechCare

Official's Role

Study Director

Facility Information:

Facility Name

The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Ospedale San Paolo

City

Milano

ZIP/Postal Code

20142

Country

Italy

Facility Name

Institute Ophthalmology - Universita di Parma

City

Parma

ZIP/Postal Code

43121

Country

Italy

Facility Name

Clinica Oculistica Universitaria - P-O Oftalmico

City

Torino

ZIP/Postal Code

10149

Country

Italy

Facility Name

Hospital Clinico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hôpitaux Universitaires de Genève

City

Genève

ZIP/Postal Code

CH-1211

Country

Switzerland

Facility Name

Clinique de Montchoisi - Glaucoma center

City

Lausanne

ZIP/Postal Code

CH-1006

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

25982212

Citation

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 2015 May 13.

Results Reference

result

Learn more about this trial

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

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