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Phakic IOL shows excellent visual results in long-term study

Although endothelial cell loss concerns still persist, the change from preop to postop UCVA was a ‘great success’ in study, physician says.

ByMichela Cimberle

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STOCKHOLM – Four years of follow-up in a large series of patients implanted with the Artisan phakic IOL shows that visual outcomes are excellent, although the rate of endothelial cell loss still causes some concerns, according to one physician.

“The success of phakic IOLs is necessarily based on the long-term complications they will produce,” Thomas Kohnen, MD, said at the meeting of the European Society of Cataract and Refractive Surgeons. “The main purpose of long-term studies is to look at endothelial cell loss and cataract formation, and we know that with these lenses both of these complications are a drawback that cannot be underestimated.”

Good results

The Artisan (Ophtec) is a consolidated iris-claw lens model that is made entirely of rigid PMMA and comes in 5-mm and 6-mm optical zone sizes.

“We have retrospectively analyzed the results of 224 eyes of 116 patients implanted in our clinic in Frankfurt over the last 4 years. The mean preoperative spherical equivalent was –11.23 D, ranging up to –31.5 D. We implanted 192 eyes with the 6-mm optic model and 32 eyes with the 5-mm optic model,” said Dr. Kohnen, a professor of ophthalmology at the Johann Wolfgang Goethe University in Frankfurt, Germany.

The change from preoperative to postoperative uncorrected visual acuity was “a great success,” he said.

Preoperatively, all patients were 20/63 or worse, and after Artisan implantation, 75% were between 20/25 and 20/16 uncorrected.

Predictability was high, with 30% to 40% of the eyes within ±0.5 D, 90% within ±1 D and 100% within ±2 D of intended correction. Best corrected visual acuity was stable over time.

Halos and glare were classified as mild, medium and severe and were evaluated through a questionnaire.

“We had 29 eyes with mild halos, 43 with mild glare, six cases of medium glare and six of medium halos. Severe glare was reported by only two patients, who had been implanted with a 5-mm optic IOL, which was undersized in respect to the pupil. Six or 7 years ago, we were not so concerned about pupil sizes in determining and selecting [phakic] IOL lenses,” Dr. Kohnen said.

Mean postoperative astigmatism decreased from the preoperative –1.42 D, and between 1 month and 4 years it was steady at –0.8 D.

Endothelial cell loss may be preventable in the future

Changes in endothelial cell density were evaluated over the 4-year period. The mean preoperative endothelial cell density was 2,800 cells/mm², decreasing to 2,600 cells/mm² after 4 years.

“Although the majority of eyes did not show significant changes, the mean rate of endothelial cell loss was 7%, ranging from –35% to +40%,” Dr. Kohnen said.

He noted that these results are comparable to those of the 10-year follow-up in the series by Camille J. Budo, MD, and Rudy Nuijts, MD, in which the endothelial cell loss was –8.86% after 10 years, with a range of –51% to +34%.

Although less significant than with other types of phakic IOLs, these numbers give cause for concern, he said. The significant range indicates that, in a number of cases, the decrease in endothelial cell density might eventually lead to the explantation of the lens, with the consequent further loss of cells that is inevitably induced by surgery.

However, Dr. Kohnen showed an overall optimistic attitude.

“The more advanced methods of anterior chamber measurement based on high ultrasound technology and the studies that are currently carried out on the impact of these new approaches on the outcomes of phakic IOLs will enable us to determine which are the eyes that can be safely implanted with these lenses,” he said.

The data collected so far show that all lenses, including posterior chamber implants, can potentially cause endothelial cell loss. However, there are a number of cases in which no significant endothelial cell loss has occurred, Dr. Kohnen said.

The challenge in future years will be to improve selection, customization, sizing methods and lens design with the aid of increasingly sophisticated imaging technologies, he said.

For more information:

• Thomas Kohnen, MD, can be reached at Johann Wolfgang Goethe Universität, Klinik für Augenheilkunde, Theodor Stern Kai 7, D-60590 Frankfurt am Maim, Germany; +49-069-6301-3945; fax: +49-069-6301-3893; e-mail: kohnen@em.uni-frankfurt.de. Dr. Kohnen has no direct financial interest in the products discussed in this article, nor is he a paid consultant for any companies mentioned.

• Ophtec, the maker of the Artisan phakic IOL, can be reached at Schweitzerlaan 15, 9728 NR Groningen, The Netherlands, +31-50-525-1944; fax: +31-50-535-4386; Web site: www.ophtec.com.

• Michela Cimberle is an OSN Correspondent based in Treviso, Italy, who covers all aspects of ophthalmology. She focuses geographically on Europe.