Health Condition 1: H401- Open-angle glaucoma Health Condition 2: H408- Other glaucoma
Conditions
Interventions
Intervention1: Gore Glaucoma Drainage Implant: Treatment of primary open-angle glaucoma that is uncontrolled by hypotensive medications or for which conventional incisional glaucoma surgery would be m
Sponsors
LV Prasad Eye Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of primary or secondary refractory glaucoma with poor response to conventional medical, laser or surgical therapy 2. Patients without significant conjunctival scarring 3. Patients able to comprehend the study requirements and provide written informed consent willing to follow study instructions, procedures, and able to return for all follow-up examinations.
Exclusion criteria
Exclusion criteria: 1. Diagnosis on exfoliating, pigmentary, neovascular, uveitic or congenital glaucoma 2. Diagnosis of active bacterial conjunctivitis, corneal ulcers, endophthalmitis, orbital cellulitis, sinusitis, blepharitis, local skin infection, bacteremia o spticemia, scleritis 3. Active, chronic, or recurrent uveitis 4. Previous scleral buckling procedure or silicone oil 5. Expected inability to implant the study device in the superotemporal quadrant 6. Pregnant or nursing women or women of childbearing potential not willing to use medically acceptable birth control from screening through follow-up 7. Known or suspected allergy or hypersensitivity to the device 8. Any concurrent surgery in the study eye 9. Current participation or participation with the past 30 calendar days in another drug or device trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of treated eyes with = 20% decrease in mean diurnal IOP at 6 months while maintaining the same or fewer number of hypotensive medications as at baseline.Timepoint: 3, 6, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The device safety will be evaluated by assessing the following: Slit lamp & fundus examination findings, incidence & severity of ocular adverse events that include: Intraocular inflammation, infection, subconjunctival device stability, conjunctival health, bleb characteristicsTimepoint: 3, 6, 12 months | — |
Countries
India
Contacts
Public ContactDr. Sirisha Senthil FRCS
LVP Prasad Eye Institute
Outcome results
None listed