Glaucoma
Conditions
Keywords
Glaucoma, Cyclocoagulation, HIFU - High Intensity Focused Ultrasound, Ciliary Body
Brief summary
The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients
Interventions
DEVICEUltrasound glaucoma treatment
Ultrasound glaucoma treatment 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
* Primary Open-angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma * IOP \> 21 mm Hg on glaucoma medications, and indicated for filtering glaucoma surgery * Patient must be aged 18 years and more * No previous cyclophotocoagulation procedure in the eye * No previous laser treatment in the eye during the 3 months before HIFU procedure
Exclusion criteria
* History of previous glaucoma surgery with implantation of glaucoma drainage device in the study eye * History of ocular or retrobulbar tumor * retinal detachment, choroidal hemorrhage or detachment * Ocular infectious diseasee within 14 days before HIFU procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20% | up to 12 months | Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication) |
Secondary
| Measure | Time frame |
|---|---|
| Average change in IOP (mm Hg) | 3, 6 and 12 months |
| Percentage change in IOP from baseline | 3, 6 and 12 months |
| Average change in glaucoma hypotensive medications | 3, 6 and 12 months |
| Incidence of device and procedure-related complications during follow-up | 3, 6 and 12 months |
Countries
France
Outcome results
None listed