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K. Hori, J. Hamuro, C. Sotozono, S. Kawasaki, N. Yokoi, H. Ueda, Y. Tabata, S. Kinoshita; A Newly Developed Biodegradable Punctal Plug With Controlled bFGF Release for Permanent Lacrimal Punctal Occlusion: Preliminary Results. Invest. Ophthalmol. Vis. Sci. 2008;49(13):104. doi: https://doi.org/.
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Surgical permanent punctal occlusion is indicated for patients with severe dry eye when conventional treatment fails, however, it is difficult to obtain complete occlusion since reopening often occurs after the operation. bFGF is a vital growth factor that promotes formation of granulation tissue and capillaries, by stimulating proliferation and differentiation of fibroblasts and endothelial cells. We have previously demonstrated that gelatin hydrogels can release biologically active bFGF in a controlled manner, thereby successfully enhancing angiogenesis or regeneration of other tissues. Here we report that in an attempt to establish a more successful occlusion, we have experimentally fabricated a biodegradable plug with controlled bFGF release for induction of connective tissues into the lacrimal canaliculi, and evaluated its effect in the canaliculi of a rabbit.
A biodegradable plug was fabricated from collagen solution and polyester non-woven fabric, that incorporated gelatin microspheres containing 30µg of bFGF. The plugs were placed into lacrimal canaliculi from which epithelia and superficial subepithelial tissue were mechanically scraped using a hand motor drill, and then fixed by 9-0 nylon sutures (n=4). A sham operation without plug insertion was performed as a control (n=2). The puncta were examined microscopically during the postoperative time course, and at 2 month after the operation the canaliculi and surrounding tissues were evaluated histologically.
In canaliculi that received the plugs, puncta were occluded by the remaining plug fragment and newly formed granulation tissues at approximately 1 month. Histological observation revealed that tissues in the canaliculi were composed of remaining polyester fibers and many fibroblast-like cells, and appeared similar to the surrounding connective tissues, occupying what was previously the canalicular cavity. In canaliculi that did not receive the plug, the punctum was sutured and occluded; although it had narrowed, the cavity remained histologically open.
The biodegradable plugs gradually degraded with time and at the end of the study were being replaced by new connective tissue. Controlled release facilitated by this new plug may have enabled bFGF to promote induction of granulation tissue into the canaliculi. This plug therefore shows promise for the treatment of severe dry eyes.
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