Glaucoma
Conditions
Keywords
Glaucoma, Cyclocoagulation, HIFU High Intensity Focused Ultrasound
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
Interventions
DEVICEEYEOP1
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device
Sponsors
EyeTechCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoint : Success / failure rate at 1 year | 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety measures | 12 months | Number of device and procedure-related and others complications during follow-up |
Countries
Israel, Italy, Spain, Switzerland
Outcome results
None listed