Health Condition 1: null- Glaucoma
Conditions
Interventions
Intervention1: Cyclo Coagulation using High Intensity Focused Ultrasound: EyeOP1 medical device is used for treatment of refractory glaucoma by decreasing the production of aqueous humor, thereby redu
Sponsors
EyeTechCare
Eligibility
Inclusion criteria
Inclusion criteria: 1.Primary Open Angle or Angle Closure Glaucoma and Secondary Glaucoma 2.Patient with no vision potential or blind eyes 3.No previous intraocular surgery or laser treatment during the 90 days before HIFU Day 4.Any patient with/without previous conventional glaucoma surgery failure 5.Angle closure glaucoma or narrow anatomical anterior chamber as identified by gonioscopy and classified as Shaffer Grade 0 or 1 6. Any patient with/without previous conventional glaucoma surgery failure
Exclusion criteria
Exclusion criteria: 1. Patient who has been diagnosed for normal tension glaucoma 2. Glaucoma drainage device implanted and still presented in the eye to be treated 3. Ocular or retrobulbar tumor 4. Ocular infection within 14 days prior to the HIFU procedure 5. Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of Intraocular Pressure relative to the pre-operative value will be assessed at each follow-up visit with the final measurement of success at 3 months.Timepoint: Day 1, Day 7, Month 1, Month 2, Month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Efficacy parameters and success rate 2) Safety parametersTimepoint: 1.1) Mean IOP at each follow-up visit compared to baseline IOP 1.2) Mean IOP variation compared to the baseline at each follow-up visits 1.3) Number of ocular hypotensive medications at each follow-up visits 2.1) Rate of per-operative device and/or procedure-related Adverse Events 2.2) Rate of post-operative device and/or procedure-related complications and adverse events at each follow-up visit | — |
Countries
India
Contacts
Public ContactNaresh Kumar Pagidimarry
Maxivision Super Speciality Eye Hospital
Outcome results
None listed