Teresa Gumula

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.

Non-penetrating very deep sclerectomy with a hydrophobic polymer implant in a rabbit model

PURPOSE The aim of the study was to evaluate the influence of an implant made of a terpolymer (PTFE-PVDF-PP) on the condition of rabbit eyes during a one year observation period. METHODS The implant in the shape of an equilateral triangle (3 mm side length) was manufactured from a thin hydrophobic porous membrane. There were evaluated 40 eyes of 20 rabbits. The animals had non-penetrating very deep sclerectomy (NPVDS) performed, with insertion of an implant in the form of a triangular thin membrane. The control group consisted of 20 eyes where the animals had NPVDS performed without implant insertion. The evaluations included the study of the anterior part of the eye together with photographic documentation. Histopathological examination of the eyes 52 weeks after NPVDS procedure has been made. The process of wound healing was comparable in both groups. RESULTS The evaluation of the rabbits did not reveal any acute process of intraocular inflammation. After 12 month period of observation, no statistically significant differences in the process of wound healing or status of eyes were found between the groups. An analysis of fibrous connective tissue attachment to the implant showed that its layer was not thick and did not differ significantly from the control. The procedure of very deep sclerectomy and insertion of a polymer implant were well tolerated by the rabbit eyes. CONCLUSIONS The in vivo results indicate that the hydrophobic implant in the form of a membrane can serve as a sclera implant after further study.