Health Condition 1: null- No vision refractory glaucoma
Conditions
Interventions
Intervention1: High Intensity Focused Ultrasound Therapy: Ultrasound duration for 6 seconds per transducer 2 times
consecutively
Control Intervention1: High Intensity Focused Ultrasound Therapy 2: Ult
Sponsors
EYE TECH CARE
QAscent Research Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Patient with no potential or blind eye • Glaucoma patients whose IOP is not well controlled with glaucoma medication • IOP more than 21 mmHg • Open Angle Glaucoma, secondary Glaucoma patients or Angle closure glaucoma (ACG). • Any patients with previous conventional glaucoma surgery failure or end stage glaucoma patient indicated or contraindicated for conventional filtering surgery • No previous intraocular surgery or laser treatment during the 90 days before HIFU Day
Exclusion criteria
Exclusion criteria: • History of cyclo-destructive procedures • History of ciliary body surgery • History of ocular or retrobulbar tumor • Ocular infection within 14 days • Eyes with implantation of glaucoma drainage device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of IOPTimepoint: D7, M1, M3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean IOP (mmHg)Timepoint: D7, M1, M3;Mean IOP variation compared to the baseline (mmHg Hg) Timepoint: D7, M1, M3;Number and Mean number of ocular hypotensive medicationsTimepoint: D7, M3, M3;Safety Events Incidence of all device and/or procedure follow-up period Timepoint: full follow up period | — |
Countries
India
Contacts
Public ContactSubhash Sugathan
QASCENT RESEARCH SOLUTIONS PVT. LTD.
Outcome results
None listed