Health Condition 1: null- Primary Open Angle Glaucoma
Conditions
Interventions
Intervention1: High Intensity Focused Ultrasound Cyclo Coagulation: Treatment of Primary open angle glaucoma using High Intensity Focused Ultrasound System, Frequency - 21 Mhz, Duration 10s, Delay ti
Sponsors
EyeTechCare
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with Primary Open Angle Glaucoma or Pseudo-exfoliative Glaucoma or Pigmentary Glaucoma 2. Patients with/without prior filtering glaucoma surgery 3. Patients where the IOP is not adequately controlled with glaucoma medication, with IOP between greater than or equal to 21 mm Hg and less than or equal to 45 mm Hg 4. No previous intraocular surery or laser treatment during the 90 days before HIFU day 5. Patient able and willing to sign approved informed consent form and agrees to attend all postoperative follow-up visits
Exclusion criteria
Exclusion criteria: 1. Angle closure glaucoma or narrow anatomical anterior chamber as identified by gonioscopy and classified as Shaffer Grade 0 or 1 2. Patients diagnosed with any type of Secondary Glaucoma 3. Glaucoma drainage device implanted and still present in the eye to be treated 4. Previous cyclodestructive procedure in the eye to be treated 5. History of ocular or retrobulbar tumor 6. Ocular infection within 14 days prior to the HIFU procedure 7. Aphakic patient 8. Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful reduction of intraocular pressure relative to the baseline value will be assessed at 6 months (Success rates and Mean IOP variation in %)Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Success/Failure rates at Month1, Month2 and Month3 post-operative visits (% and number of patients) 2. Mean IOP (mm Hg) at follow-up visits (Day1, Day7, Month1, Month2 and Month3) compared to the baseline IOP 3. Mean IOP variation compared to the baseline (%) at follow-up visits (Day1, Day7, Month1, Month2 and Month3) 4. Number of ocular hypotensive medications at each follow-up visitsTimepoint: Day 1, Day 7, Month 1, Month 2 and Month 3 | — |
Countries
India
Contacts
Public ContactNaresh Kumar Pagidimarry
Maxivision Super Speciality Eye Hospital
Outcome results
None listed