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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
Sponsored by
EyeTechCare
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
May 4, 2012
Last Updated
June 15, 2015
Sponsor
EyeTechCare
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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
No
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

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

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