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7-year follow-up of AcrySof IOL continues to show good visual acuity and low PCO
No explants to date have been necessary for 21 patients.
--- Epithelial proliferation but central capsule spared at 7 years 4 months after surgery.
VIENNA, Austria — A 7-year follow-up study of 21 patients implanted with the AcrySof MA60-BM IOL (Alcon, Fort Worth, Texas) indicates good long-term visual acuity and low levels of posterior capsule opacification (PCO).
“My patients continue to be delighted with this lens and so do I,” said Richard B. S. Packard, MD, FRCS, a consultant surgeon in the eye unit at HRH Princess Christians Hospital here. “We’ve seen good visual acuity, with all 21 patients achieving 20/30 or better at 7 years.” Moreover, 12 of the 21 patients are 20/20 or better.
The study group consisted of 11 British and 10 German patients (19 female, two male) with a mean age of 74.4 years (60 to 83) at the time of cataract surgery. All surgeries were performed between December 1990 and November 1991 at either a district general hospital in the United Kingdom or at a teaching hospital in Germany. Of the 16 subjects, five had preoperative ocular conditions (one glaucoma, one glaucoma and guttata, two age-related macular degeneration [AMD], one AMD and guttata). The average follow-up period was 7 years, 2 months.
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Low PCO rate
Dr. Packard was an original investigator for the Alcon Food and Drug Administration core trial group and implanted the AcrySof in all the 11 British patients included in this long-term follow-up study. One finding is that the PCO rate has been very low, with only four of the overall 21 patients undergoing a Nd: YAG posterior capsulotomy at 3.5 years, 4 years, 5 years and 6 years after initial surgery. “However, none of these four capsulotomies were performed on my own patients. They were all German patients,” Dr. Packard said. PCO as epithelialization was absent in eight of the 21 eyes, and mild and peripheral in nine eyes.
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In addition, there has been no intralenticular glistenings evolving over time. “At the 5-year stage, we specifically looked at glistenings, too,” Dr. Packard related. He noted, though, that “a lot of surgeons try to make an issue out of glistenings with the AcrySof. But if you look at the number of patients who have had their lens explanted in comparison to the total number of implants, we are talking about less than 0.001%.” In any event, glistenings are “water vacuoles that are very tiny and do not affect visual acuity whatsoever.” About 50% of the study patients had some degree of glistenings.
The AcrySof also has remained stable, with no cases of lens decentration. “The anterior capsules have remained fairly clear, as well,” Dr. Packard reported. “There is no indication of anterior capsular contraction.” Furthermore, there has been no lens tilt and none of the lenses have had to be explanted.
“The AcrySof provides very good best corrected visual acuity, but then so do may other foldable IOLs,” said Dr. Packard, who presented results at the annual meeting of the European Society of Cataract and Refractive Surgeons. “We use the AcrySof for everything — backup, in-the-sulcus, uveitis, in children and in our glaucoma patients.” Still, “it is a different type of lens. There is a learning curve, especially for surgeons who are used to silicone lenses. The material behaves completely different. The AcrySof is not a rubber material; it is malleable with a memory. However, people who come straight from PMMA don’t seem to have a problem. These surgeons don’t have preconceived notions on how the AcrySof will behave.”
Dr. Packard noted that the AcrySof is the first foldable lens with a square-edge design. “This achieves a lower PCO rate,” he said. “If surgeons in the United States could significantly reduce the number of capsulotomies, their government would save huge amounts of money on Medicare reimbursements.” Yet a square-edge design can cause some internal reflections and edge glare. “But if the anterior capsulotomy covers the edge of the IOL, this patient complaint generally ceases to be an issue,” Dr. Packard said.
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For Your Information:
- Richard B. S. Packard, MD, FRCS, can be reached at HRH Princess Christians Hospital, 12 Clarence Road, Windsor, Berkshire SL4 5AG, England; (44) 1753-829-204; fax: (44) 175-383-1185. Dr. Packard did not participate in the preparation of this article.
- Alcon can be reached at 6201 South Freeway, Fort Worth, TX 76134; (800) 862-5266; fax: (817) 241-0677.