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D F Sweeney, R Z Xie, D J O'Leary, A Vannas, R Odell, K Schindhelm, H Y Cheng, J G Steele, B A Holden; Nutritional requirements of the corneal epithelium and anterior stroma: clinical findings.. Invest. Ophthalmol. Vis. Sci. 1998;39(2):284-291.
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PURPOSE: To monitor the health of the epithelium and the anterior stroma when porous membranes are implanted into the feline cornea and to determine membrane diffusivity characteristics needed to maintain corneal integrity. METHODS: Filtration membranes in a range of effective pore sizes of less than 15 nm (groups 1 and 2, n = 11), 25 nm (group 3, n = 8), 50 nm (group 4, n = 16), and 100 nm (group 5, n = 15) were implanted into an interlamellar corneal pocket of the stroma. The implanted membranes ranged in thickness from 6 nm to 15 nm and were between 8 mm and 12 mm in diameter. Animals were monitored for clinical signs of intolerance to the implants. RESULTS: At 1 month, thinning and ulceration had occurred in the epithelium and the anterior stroma of all animals in groups 1 and 2; epithelial changes, anterior stromal thinning, and ulceration had developed in 75% of animals of group 3; 50% of animals showed vascularization and only 7% showed epithelial degeneration in group 4; and local anterior stromal thinning was observed in 7% of animals in group 5, indicating clinical acceptance of the implanted membrane. In the long term (greater than 50 days), 30% and 73% of the group 4 and 5 corneas, respectively, were clinically quiet. Analysis of the failure times indicated an inverse relation between failure rate and pore size: less than 15 nm > 25 nm > 50 nm > 100 nm. The difference between the 100-nm and 50-nm membranes was significant (P = 0.03). CONCLUSIONS: A corneal implant must have a porosity greater than that provided by 50-nm membranes. The 100-nm membranes used in this study establish the porosity needed to satisfy the nutritional requirements of the cornea.
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