Health Condition 1: H401- Open-angle glaucoma
Conditions
Interventions
Intervention1: Calibreye (Trade Mark) System: This is a minimally invasive glaucoma surgery (MIGS) device to be implanted once in the study eye.
Control Intervention1: NIL: NIL
Sponsors
Myra Vision,Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of open angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma 2. IOP at one preoperative visit of >= 18 mmHg and 3. Visual field mean deviation score of -3dB or worse 4. Area of healthy, free and mobile conjunctiva in the target quadrant 5. Trabecular meshwork visible on gonioscopy 6. Shaffer angle grade >= 3 in the target quadrant 7. Age 18 years or older and of legal age of consent 8. Signed written informed consent 9. Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and schedule
Exclusion criteria
Exclusion criteria: 1. Angle Closure Glaucoma 2. Congenital, neovascular or other secondary glaucomas developed as a complication of other medical conditions (e.g., intraocular surgery, ocular injury, ocular tumor, or uveitis) or from use of medications (e.g., corticosteroids) 3. Previous intraocular surgery (with the exception of laser trabeculoplasty or uncomplicated phacoemulsification with IOL, occurring > 3 months prior to the preoperative visit) 4. Previous glaucoma shunt/valve in the target implant area 5. Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) 6. Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant 7. History of corneal surgery, corneal opacities or corneal disease 8. Central corneal thickness = 620 microns 9. Active iris neovascularization or neovascularization of iris within 6 months of preoperative visit 10. Vitreous present in the anterior chamber 11. Aphakia, anterior chamber intraocular lens or previous complicated phacoemulsification surgery 12. Either eye with best corrected visual acuity worse than 20/400 13. Presence of intraocular silicone oil 14. Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, macular edema or other ophthalmic disease or disorder that could confound study results 15. Anticipated need for ocular surgery or retinal photocoagulation during the 12- month follow-up period 16. Impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos) 17. Ocular or systemic steroid use within three months prior to the preoperative visit 18. Requiring anticoagulation therapy other than baby aspirin (up to 100 mg) at the time of surgery 19. Known or suspected allergy or sensitivity to drugs required for the protocol (including anesthesia), or any of the device components (e.g., porcine products, or glutaraldehyde) 20. Uncontrolled systemic disease (e.g., diabetes, hypertension) 21. Pregnant or nursing women 22. Participation in another drug or device clinical trial concluding within 30 days of the preoperative visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety parameters to be evaluated are incidence & severity of ocular adverse events. 2. Effectiveness will be evaluated by comparing baseline intraocular pressure values to postoperative values. Timepoint: Preoperative, Operative, 1 Day, 3 Days, 1 Week, 2 Weeks, 3 Weeks, 1 Month, 2 Months, 3 Months, 6 Months, 9 Months, & 12 Months. | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: Not Applicable | — |
Countries
Georgia, India, Mexico, Panama
Contacts
Public ContactDr Vinod Gyanchandani
Dr. Agarwals Eye Hospital
Outcome results
None listed