Everpatch- A Synthetic Substitute For Tissue In Drainage Device Surgeries, First In Human Results- 1 Year Follow Up Data

Assessing the safety of a synthetic and non-degradable substitute for tissue in ophthalmic surgery, specifically for the concealment of glaucoma drainage devices.

Da-Vinci Eye clinic, Tbilisi Georgia- Dr. Nikolouz Labauri

12 patients were recruited for this study and followed up post op for a year. Patients underwent Baerveldt® Glaucoma Implant insertion. The Everpatch was used to conceal the tube when it exited the sclera and posteriorly towards the fornix in a similar way to harvested or processed tissue that is considered the standard of care. The conjunctival flap was dissected in a fornix-based approach. Closure of the conjunctival tissue was performed away from the synthetic patch in a way that the incision laid over the patient sclera and not the synthetic patch.

Cases where the incision dehisced were taken back to the operating room and surgically corrected.

Of the 12 patients that were included in this study all reached their 12 months follow up visit. 2 patients had early dehiscence of the conjunctival wound. Both had previous conjunctival surgery, one had ICE syndrome. No late complications occurred, and no tube exposure was observed.

In this clinical trial we report the first use of a synthetic and non-degradable substitute for tissue in ophthalmic surgery. The most dreaded complication of tube shunt surgery is late exposure of the tube with resultant endophthalmitis. In this small cohort of patients followed up prospectively no tube exposures were noted at the one year follow up timepoint.