Abstract
Purpose: :
To study the efficacy of the polymer track membrane with nanostructured surface as a drainage material in the surgery of refractory glaucoma.
Methods: :
10 μm-thick polyethylene terephthalate and polycarbonate track membranes with an effective pore diameter of 400 nm were used. For nanostructuring, surface of the membranes was treated by air plasma by means of a plasma-chemical reactor using a RF-discharge (13.56 MHz). The obtained drainage systems were implanted into the anterior chamber and scleral layers of rabbits (60 eyes). Animals were sacrificed in 6 and 12 months, and histological study of the eyes was performed. Further, study included 282 patients with refractory glaucoma: 147 patients (159 eyes) underwent deep sclerotomy and subsequent implantation of the drainage with nanostructured surface; 135 patients (149 eyes) underwent deep sclerotomy and implantation of drainage without nanostructure. Follow-up period for the patients was 24 months.
Results: :
Histological study of the rabbits' eyes demonstrated minimal or no inflammation around the drainage system. At the 12-month time point, the implant did not show destruction; its porous structure was fully preserved; fibrosis around the implant was mild. Patient study demonstrated that in 24 months after surgery, stable hypotensive effect was achieved in 95% of the patients of group I, and in 72% of the patients in group II. In all patients of group I, filtration blebs were well-defined, flat and well-extended; no signs of inflammation, cell infiltration, corneal or iridal neovascularization, anterior or posterior synechia were observed.
Conclusions: :
Morphological and clinical studies of the nanostructured track membranes used as drainage systems for anti-glaucomatous surgeries demonstrated their compatibility with the eye tissues. The new drainage provides long-lasting hypotensive effect and is safe in the surgery of refractory glaucoma.
Keywords: intraocular pressure • anterior segment • clinical (human) or epidemiologic studies: systems/equipment/techniques