New injectable lenses show promise in the restoration of accommodation

Roibeard OhEineachain in Paris

ACCOMMODATION may, in the future, be restored to cataract patients and presbyopes through injection of a fluid silicone material that fills the capsular bag and remains pliable like the natural pre-presbyopic crystalline lens, according to two studies presented at the XXII Congress of the ESCRS. The concept behind one of the new fluid injectable lenses is that the surgeon will remove the natural lens through a small capsulorhexis opening in the periphery of the capsular bag and inject the refilling material through the same opening, explained Steven Koopmans MD, University of Groningen, the Netherlands. Dr Koopmans noted that one of the problems they had to overcome in the course of their research was devising a means to prevent postoperative inflammation and capsular fibrosis after monkey implantations.They therefore developed a new protocol for implanting the material which involves treating the capsule with a new compound developed by AMO that prevents PCO followed by subconjunctival injection of triamcinolone, and the application of antibiotic and steroid eyedrops for the first two postoperative weeks. The researchers found that eyes that underwent injection of lens material according to the new protocol remained relatively clear. By comparison, one eye that underwent injection without the new protocol developed considerably more fibrosis in the centre of the capsule and became increasingly myopic due to shrinkage of capsular bag One of the hurdles yet to be overcome is the development of a method of determining either pre- or intraoperatively how much fluid to inject in the capsule for optimal refractive results. We now have a material that allows accommodation in both in vitro and in vivo experiments, which fulfils all requirements necessary for an injectable IOL. Material is therefore not a limiting factor and we can continue to work on other issues as we head towards clinical trials, Dr Koopmans added. The rhexis-capping approach Okihiro Nishi MD in Osaka, Japan is working on another approach to fluid injectable IOLs. His technique involves removing the crystalline lens through a standard capsulorhexis, filling the capsule with a fluid silicone mixture and then capping the rhexis with a special capsulefitting lens. Eyes undergoing the procedure would have two simultaneous mechanisms of accommodation; the forward movement of the lens and an increase in the thickness of the fluid in the capsule, Dr Nishi told the Paris Congress. The capsule-fitting lens has an overall length of 13.0 mm and a thickness of 1.2 mm.The optic of the lens has three components, an anterior optic of 6.0 mm, a posterior optic of 6.5 mm and a real optic of 5.5 mm. The shape is similar to that of a conventional IOL, but the optic has small narrow groves over its entire circumference.The CCC edge is put in this groove, which chokes the IOL, preventing leakage of the injected material. Experiments in rabbit eyes have shown that the capsulefitting lenses are effective in preventing leakage of the fluid silicone material and that the material can completely fill the capsular bag. To perform the procedure Dr Nishi first extracted the crystalline lenses from the eyes via phacoemulsification through a 3.00mm -4.5 mm capsulorhexis. He then placed the lens inside the capsular bag and used a Sinskey hook to manoeuvre the lens so that the grooves of the optic captured the edge of the rhexis. He then pulled back a small portion of rhexis edge with a Sinskey hook and injected the fluid silicone material. The lens capsule that was closed by the IOL was well refilled.The slight amount of the injected material that leaked during the injection could be easily removed from the anterior chamber by aspiration at the end of surgery. When the CCC choked the IOL loosely, there was leakage after the injection. Dr Nishi noted that, in addition to preventing leakage, the lens also appeared to prevent anterior capsule fibrosis. However, PCO remained a problem. He added that tests of the lenses accommodative amplitudes await trials in primate eyes and he suggested that a light-adjustable version of the lens might enable patients with the lens achieve optimal refractive results. The IOL has proven to be effective on preventing leakage of the injected liquid material with high reproducibility, when CCC was created at a proper size. This new lens refilling procedure appears to be promising, he added.
s.a.koopmans@ohk.azg.nl okihiro@nishi-ganka.or.jp

Steven Koopmans

Okihiro Nishi

We think that the most promising concept for restoring lost accommodation is an injectable intraocular lens.
We think that the most promising concept for restoring lost accommodation is an injectable intraocular lens. In vitro and animal experiments show that two new candidate materials fulfil the physical and biocompatibility

requirements to serve as a replacement lens.The studies also show that the injected lenses can retain their original resting refraction throughout three months of follow-up, he noted. The two new candidate materials, developed by AMO, are composed of silicone and have different accommodative capabilities. One material has the modulus (stiffness) of the lens of a 20-year-old human eye, while the other has that of the lens of a 40-year-old. Both materials have a specific gravity and an index of refraction close to that of the crystalline lens. Stretch ring Experiments with human cadaver eyes show that the refilled lenses achieved a mean accommodative amplitude of approximately 4.0 D with the 40-year-old material and

approximately 8.0 D with the 20-year-old material. Moreover the accommodative amplitude of the refilled lenses was independent of the age of the eye donor at the time of death. To perform the implantation Dr Koopmans first removed the cornea and iris from the cadaver eyes, made a small peripheral capsulorhexis, extracted the natural lens and injected the silicone material into the intact capsule. He then explanted the capsules with the ciliary body and zonules still attached and tested their accommodative amplitudes using a special stretch ring device designed and built by Adrian Glasser and Chris Kuether at the College of Optometry, University of Houston. After attaching the ciliary body to the stretch ring with sutures, Dr Koopmans and his associates measured the degree to which the lens would flatten as the sutures pulled on the ciliary body, he explained. Monkey eyes Subsequent in vivo experiments performed in the lab of Dr Adrian Glasser in Houston showed that the material retained relatively good optical quality when implanted into the capsular bags of monkeys eyes and that monkeys implanted with the material achieved accommodation of about 6 diopters directly postoperative. In addition, in experiments conducted in the Netherlands, Ascan measurement showed the thickness of refilled lens increased from 4.1 mm to 4.4 following pilocarpine eyedrops.

Courtesy of Steven Koopmans

Monkey fundus as seen through a refilled lens