The Calibreye TGT Surgical System is intended to offer an adjustable solution to control IOP in patients with glaucoma.
The Calibreye is being evaluated as an Investigative Device Exemption (IDE) device, under the ADAPT trial. The first patient for the trial was recently enrolled by Myra Vision, the company involved in the manufacture of the device.
The ADAPT trial is a prospective, multicenter, nonrandomized open-label study that will enroll up to 70 refractory glaucoma patients with a 12-month primary effectiveness endpoint. The clinical investigation will evaluate the safety and effectiveness of the company’s titratable glaucoma therapy system, designed to optimize IOP reduction in patients undergoing glaucoma surgery. Once implanted, the Calibreye aqueous shunt is designed to enable slit lamp-based outflow adjustments as individual patient requirements evolve over time.
The Calibreye has the following specifications:
10.0 x 1.6–mm overall dimensions intended to provide posterior bleb formation to increase aqueous drainage.
Low profile (0.30 mm thick) to help maximize patient comfort and minimize erosion risk.
Suture eyelets for a secure shunt placement.
Visual indication for confirmation of channel settings.
Uses materials with well-known ophthalmic biocompatibility:
Silicone
- Hydrophobic properties help reduce protein binding to minimize cellular adhesion.
- Flexible and stable polymer with minimal biodegradation in vivo.
- Hyperemia is milder than with stainless steel
- Inflammatory response is milder than with polypropylene used in other devices.
Valve components composed of nitinol, a material with a proven history of use in ocular applications.
A multi-center international feasibility study involving Calibreye implantation, enrolled 43 patients with moderate to late-stage disease, of which 33 patients had greater than 3 months of follow-up, at four sites in three countries.
The 3-month clinical trial results presented demonstrated:
- 44.9% intraocular pressure (IOP) reduction compared to baseline, with an average IOP of 12.1 mmHg.
- 88% of patients were medication-free, with 100% of patients on less than or equal to the number of meds at baseline.
- Over 96% mean medication reduction compared to baseline, equating to a mean reduction of over 3 medications per patient.
- No patients required bleb needling procedures.
- 100% of devices implanted successfully, 100% of titrations completed successfully with an average of 2.2 titrations per patient.
