Health Condition 1: H401- Open-angle glaucoma
Conditions
Interventions
Intervention1: Ultrasound Ciliary Plasty (UCP): Group-1:Ultrasound Ciliary Plasty using High Intensity Focused Ultrasound
Dose: Ciliary Body circumference treated by ultrasound at 210° wherein 8 sectors will be activated 48 seconds (i.e. 6 seconds/sector)
Duration: Single Treatment Dose on Day 0
Control Intervention1: Ultrasound Ciliary Plasty (UCP): Group-2:Ultrasound Ciliary Plasty using High Intensity Focused Ultrasound
Dose: Ciliary Body circumference treated by ultrasound at 260° wherein 10 sectors will be activated 60 seconds (i.e. 6 seconds/sector)
Duration: Single Treatment Dose on Day 0
Sponsors
EYE TECH CARE
QAscent Research Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Glaucoma patients whose IOP is not well controlled with 2 or glaucoma medication 2. IOP >= 25 mmHg 3. Primary Open Angle Glaucoma (POAG) including Pigmentary Glaucoma (PG), PseudoExfoliative Glaucoma (PXFG)). 4. Any patients with previous conventional glaucoma surgery failure (such as Trabeculectomy and/or Deep Sclerectomy), or end stage glaucoma patient indicated or contraindicated for conventional filtering surgery (e.g. Trabeculectomy) 5. No previous intraocular surgery or laser treatment during the 90 days before Ultrasound Ciliary Plasty Day in the study eye. 6. Age > 18 years and 7. Able and willing to sign the informed consent form and complete postoperative follow-up requirements.
Exclusion criteria
Exclusion criteria: 1. History of cyclo-destructive procedures (cryotherapy, diode laser cyclo-destruction, and endo-photo-coagulation) in the study eye. 2. History of ciliary body surgery in the study eye 3. History of ocular or retrobulbar tumor in the study eye 4. History of vitrectomy in the study eye 5. Ocular infection within 14 days prior to the procedure of Ultrasound Ciliary Plasty (both eye) 6. Eye with implantation of glaucoma drainage device 7. Neovascular glaucoma with or without hyphema and/or vitreous haemorrhage 8. Structure abnormalities in anterior segment which lead to excessive scleral expansion or change of ciliary body location 9. Ocular disease other than glaucoma that may affect assessment of IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, and retinal detachment) 10. Any other systemic illness as per investigatorâ??s discretion which will jeopardize patientâ??s participation in the study. 11. Any patient currently participating in another drug or device study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IOP Reduction in % (i.e 20% or more) on same or fewer IOP Lowering MedicationTimepoint: Baseline & Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Mean IOP (mmHg) Timepoint: Baseline & Day-1, Day-7, Month-1, Month-2, Month-3, Month-4 & Month-6;Mean IOP Variation (%)Timepoint: Baseline & Day-1, Day-7, Month-1, Month-2, Month-3, Month-4 & Month-6;Mean number of Ocular hypotensive medicationsTimepoint: Day-1, Day-7, Month-1, Month-2, Month-3, Month-4 & Month-6;Reduction in Intraocular PressureTimepoint: Baseline & Day-1, Day-7, Month-1, Month-2, Month-3, Month-4 & Month-6 | — |
Countries
India
Contacts
Public ContactSubhash Sugathan
QAscent Research Solutions Pvt. Ltd.
Outcome results
None listed