Total integration of an ocular implant/prosthesis: preliminary in vivo study of a new design.

An ocular implant designed to simplify surgical implantation, minimize infection and extrusion, and improve motility when used as a prosthetic replacement for eyes removed because of damage or disease was tested in rabbit eyes. The implant consisted of a silicone sphere with patches of porous silicone elastomer at the natural insertion sites of the extraocular muscles. Nine implants also had patch material around the base of an integral post designed to distribute the weight of and transfer motility to an overlying prosthetic conformer. Six implants without posts had a circular porous patch on the central anterior surface to facilitate closure of the conjunctiva and Tenon's capsule. Biocompatibility and feasibility were tested in rabbit eyes for < or = 1 year. The patches promoted conjunctival ingrowth, leading to positional stability, and facilitated adherence of the extraocular muscles. Patch material around the post or on the anterior conjunctival surface enhanced conjunctival closure and healing. All 15 implants were retained with no signs of migration, conjunctival dehiscence, or extrusion. Motility on forced duction testing was significant in all directions. The materials appeared to be biocompatible, and the design with the post provided good motility, with the potential for improved coordinated eye movement as a result of the specifically localized attachment of the extraocular muscles.

Synthetic scleral reinforcement materials: I. Development and in vivo tissue biocompatibility response.

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.

Collagen-based drug delivery and artificial tears.

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.

Effects of scleral reinforcement on the elongation of growing cat eyes.

OBJECTIVE: We investigated the effect of scleral reinforcement on ocular elongation in the rapidly growing eyes of juvenile cats. METHODS: Bands made from donor sclera or expanded polytetrafluoroethylene were used to reinforce one eye of each animal; contralateral eyes underwent sham surgery. RESULTS: During 5 months of follow-up, normal intraocular pressures implied normal functioning of angle structures. A-scan on the central axis showed no difference in globe lengths. Direct physical measurements of the posterior aspect of the globe at enucleation revealed significant decreases in off-center lengthening where reinforcement was present compared with unreinforced areas in the same eyes and in the contralateral unbanded eyes. Venous beading in fundus photographs of three eyes suggested impairment of venous outflow. CONCLUSIONS: Scleral reinforcement appears to control expansion of the growing cat eye to a limited extent, but the effects on vision and retinal perfusion require further investigation.