For patients with conditions requiring chronic rather than acute therapy, the advantages of collagen shields in providing high and sustained levels of drugs and/or lubricants to the cornea are outweighed by the difficulty of insertion of the shield and the problem of blurred vision. We have developed a delivery system in which collagen pieces suspended in a viscous vehicle can be instilled into the lower forniceal space, thereby simplifying application and reducing blurring of vision. The collagen pieces (Collasomes) can be formulated with various constituents such as antibiotics or cyclosporine, or with chemical alterations such as the inclusion of a lipid (Lacrisomes) for the treatment of dry eyes. In the normal eyes of volunteers, Collasomes hydrated in a solution of sodium fluorescein and suspended in a methylcellulose vehicle as a model for delivery of water-soluble drugs produced fluorescein concentrations 17 to 42 times higher in the cornea and 6 to 8 times higher in the aqueous humor, compared with fluorescein-containing vehicle alone. In a preliminary controlled study, 76% of patients with moderately severe keratoconjunctivitis sicca (KCS) preferred Lacrisomes to the vehicle control because of a more soothing effect and longer duration of comfort. All preparations were well tolerated by all study subjects. Current studies involve improving drug delivery by chemically modifying the collagen molecule to slow diffusion of the drug from the Collasome matrix, as well as varying the amount of cetyl alcohol and combining it with modified collagen in Lacrisomes to maximize comfort in patients with dry eyes.
The surgical treatment of pathological myopia involves the placement of a band cut from donor sclera around the back of the globe to provide support and to prevent elongation that leads to retinal detachment and blindness. In the search for a synthetic material that would overcome the disadvantages of the donor tissue band, we tested 11 types of bands made from 14 polymers in rabbit eyes. Bands were cut from porous and solid materials, as well as porous materials coated with solids and solid materials with porous patches affixed to the posterior surface. Criteria for suitability and biocompatibility included ease of placement and suturing, stable positioning, and absence of long-term tissue response on a cellular level. Testing included evaluation by the surgeons performing the implantations, measurement of the distance between the band and the globe, determination of fibrous capsule thickness and amount of collagen deposition, and enumeration of macrophages accumulated at the band/capsule interface. Based on the results of these studies, two of the porous materials (expanded polytetrafluoroethylene and porous polyurethane fabric) and two of the composite materials (porous polyurethane fabric coated with polyacrylonitrile and silicone with microvilli cut into the posterior surface) were selected for further study.
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