Histopathological Evaluation of a Hydrophobic Terpolymer (PTFE-PVD-PP) as an Implant Material for Nonpenetrating Very Deep Sclerectomy.

PURPOSE

The purpose of the study was to assess the biocompatibility of porous terpolymer (polytetrafluoroethylene-co-polyvinylidene fluoride-co-polypropylene, PTFE-PVDF-PP) membranes as an implant material to be placed during nonpenetrating very deep sclerectomy (NPVDS). Another study objective was to determine whether the polymer membrane under investigation could be used to manufacture a new-generation implant, which would actively delay the process of fistula closure and facilitate aqueous humor drainage.

METHODS

Histological response and tissue tolerance of the implant material were assessed. The study was performed on 38 eyeballs of 19 New Zealand white rabbits (19 implanted, 19 control). Histological assessment was carried out between 2 and 52 weeks after surgery. We routinely assessed inflammatory infiltrate, neovascularization, hemorrhage, and stromal edema as well as connective tissue attachment to the implant and adjacent tissues.

RESULTS

At 52 weeks of observation, a statistically significant difference was revealed between the study and control groups in terms of resorptive granulation, tissue, and the inflammatory infiltrate. No features of acute inflammatory response to the implant were observed, and there was an absence of histological features of acute inflammatory infiltrates and subsidence of chronic inflammatory infiltrates and resorptive granulation over time.

CONCLUSIONS

Slight fibrotic response and insignificant changes in neighboring eye tissues all indicate good tolerance to bioimplant materials. This allows for some optimism regarding the use of hydrophobic terpolymer in the construction of new intrascleral implants. However, the ultimate decision regarding its usefulness and safety in the treatment of glaucoma requires further investigation.