Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU)
This study is currently recruiting participants.
Verified March 2013 by EyeTechCare
Sponsor:
EyeTechCare
Information provided by (Responsible Party):
EyeTechCare
ClinicalTrials.gov Identifier:
NCT01592955
First received: May 4, 2012
Last updated: March 8, 2013
Last verified: March 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma |
Device: EYEOP1 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound With the EyeOP1 Medical Device. |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by EyeTechCare:
Primary Outcome Measures:
- Efficacy endpoint : Success / failure rate at 1 year [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Number of device and procedure-related and others complications during follow-up
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EYEOP1 device
cyclocoagulation HIFU
|
Device: EYEOP1
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592955
Contacts
| Contact: Laurent FARCY | lfarcy@eyetechcare.com |
Locations
| Israel | |
| The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center | Completed |
| Tel Hashomer, Israel, 52621 | |
| Italy | |
| Ospedale San Paolo | Completed |
| Milano, Italy, 20142 | |
| Institute Ophthalmology - Universita di Parma | Recruiting |
| Parma, Italy, 43121 | |
| Contact: Stefano Gandolfi, MD | |
| Principal Investigator: Stefano Gandolfi, MD | |
| Sub-Investigator: Nicola Ungaro, MD | |
| Clinica Oculistica Universitaria - P-O Oftalmico | Recruiting |
| Torino, Italy, 10149 | |
| Contact: Antonio FEA, MD | |
| Principal Investigator: Antonio FEA, MD | |
| Spain | |
| Hospital Clinico San Carlos | Recruiting |
| Madrid, Spain, 28040 | |
| Contact: Julian Garcia-Feijoo, MD | |
| Principal Investigator: Julian Garcia-Feijoo, MD | |
| Switzerland | |
| Hôpitaux Universitaires de Genève | Recruiting |
| Genève, Switzerland, CH-1211 | |
| Contact: Tarek Shaarawy, MD | |
| Principal Investigator: Tarek Shaarawy, MD | |
| Clinique de Montchoisi - Glaucoma center | Completed |
| Lausanne, Switzerland, CH-1006 | |
Sponsors and Collaborators
EyeTechCare
Investigators
| Study Director: | Laurent FARCY | EyeTechCare |
More Information
No publications provided
| Responsible Party: | EyeTechCare |
| ClinicalTrials.gov Identifier: | NCT01592955 History of Changes |
| Other Study ID Numbers: | EYEMUST-2 |
| Study First Received: | May 4, 2012 |
| Last Updated: | March 8, 2013 |
| Health Authority: | Israel : Ministry Of Health (MOH) |
Keywords provided by EyeTechCare:
|
Glaucoma Cyclocoagulation HIFU High Intensity Focused Ultrasound |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 16, 2013