[Nonbiodegradable drug-sustained capsular ring for prevention of secondary cataract. Part II: In vivo evaluation]

The appearance of a secondary cataract constitutes the most common complication of cataract surgery since the advent of phacoemulsification. Prevention is today one of the crucial challenges of research in ophthalmology. We have developed a drug-sustained capsular ring releasing 5-fluorouracil (5-FU). This system targets the goal of combining advantageous mechanical and pharmacological properties with the ability to interfere on the epithelial cellular processes of secondary cataract. This paper presents the results of animal evaluation.

The study first developed the in vitro delivery system as a preliminary step to the animal in vivo approach. After a pilot study conducted on micro pigs, lens extraction was performed on the right eye of 22 female albino rabbits. The four study groups included: group 1 (6 animals) as a control group receiving only phacoemulsification; group 2 (6 animals) receiving phacoemulsification and the implantation of a nonsustained capsular tension ring; and group 3 (6 animals) receiving a drug-sustained ring. Group 4 (4 animals), implanted with a 5-FU-sustained ring, was reserved for staged samples of aqueous humor for kinetic determination of active agent release.

Clinical evaluation based on biomicroscopy and histology showed a lesser reaction of secondary cataract in eyes with the ring. Compared to group 1, central posterior capsular opacification appeared significantly lower in density and surface in groups 2 and 3. No intraocular toxicity was observed. The poor sensitivity of the 5-FU detection method (high-performance chromatography) impaired pharmacokinetic evaluation.

The decrease in secondary cataract reaction in cases of implanted capsular ring demonstrated the advantages of its mechanical effect. However, the benefit of an additive pharmacological action related to the release of 5-FU could not be proved. Nevertheless, the theoretical concept of a drug-sustained delivery system seems attractive and thus calls for evaluation of other potential modulators of cell behavior.