Glaucoma
Conditions
Keywords
Glaucoma, Ultrasound, Ciliary body
Brief summary
The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.
Interventions
DEVICEEyeOP1 device
Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound
Sponsors
EyeTechCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Open Angle Glaucoma patient (Primary Open Angle Glaucoma (POAG) including Pigmentary Glaucoma (PG) and PseudoExfoliative Glaucoma (PXF)) * Any patients without previous conventional glaucoma surgery failure (trabeculectomy, Deep Sclerectomy, Ahmed valve, drainage device implantation, cyclo cryotherapy, Diode laser cyclo-destruction) * Subjects where the IOP is not adequately controlled with glaucoma medication, with IOP ≥ 21 mm Hg and \<30 mmHg * No previous intraocular surgery or laser treatment during the 90 days before HIFU Day * Age \> 18 years and \< 90 years * Patient able and willing to complete postoperative follow-up requirements
Exclusion criteria
* Patient who has been diagnosed for normal tension glaucoma * Ocular or retrobulbar tumor * Ocular infection within 14 days prior to the HIFU procedure * Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinically significant macular edema…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoint : Reduction of intraocular pressure | 24 months | Reduction of intraocular pressure at 24 months relative to the preoperative value assessed at each follow-up visits with the final measurement of success at 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety : rate of per and post-operative complications/adverse effects | 24 months | rate of per-operative device and /or procedure related adverse events and post-operative complications at each follow-up visits |
| Efficacy endpoint : Mean IOP (mmHg) | 24 months | Evolution of the Mean IOP (mmHg) at each visit during the follow-up period (Baseline to 24 months) |
| Efficacy Endpoint : Mean IOP variation (%) | 24 months | Mean IOP variation (%) at each visit during the follow-up period |
| Mean Number of ocular hypotensive medications | 24 months | Mean number of ocular hypotensive medication at each visit during the followup period |
Countries
Belgium, Israel, Italy, Portugal
Outcome results
None listed