Iris-fixated foldable phakic IOL shows good safety profile after 3 years

The phakic IOL was well-tolerated, and most complications were surgery-related, not lens-related, one surgeon said.

ByJared Schultz

Ramiro Salgado

Three-year follow-up with an iris-supported foldable phakic IOL demonstrated good visual outcomes and a low rate of complications, according to one surgeon.

Ramiro Salgado, MD, of Hospital Arrábida and Hospital Santo António in Portugal presented his results from a study of 115 eyes of 68 patients implanted with the Artiflex lens (Ophtec) for the correction of myopia between 3 D and 14 D.

The patient group included 47 women and 21 men with a mean spherical equivalent of –8.24 D, ranging from –3.5 D to –13 D. The mean patient age was 32 years, he said.

Study results

The refractive accuracy of the lens was well-demonstrated, according to Dr. Salgado. The majority of patients reached near plano in their final refraction, with 86% in the range of ±0.5 D, he said. Another 13.9% were within ±1 D.

The safety profile was equally strong, with more than 30% of patients gaining one or more lines of best corrected visual acuity, he said. None of the patients lost lines.

The efficacy data showed 58% of patients kept the same uncorrected visual acuity and 31% gained one or more lines of UCVA.

Endothelial cell counts were measured with a Konan noncontact endothelial microscope preoperatively and at 1, 6, 12, 24 and 36 months. Preoperatively, the mean cell count was 2,634 cells/mm². At 36 months’ postop, the mean cell count was 2,754 cells/mm ².

In an e-mail to Ocular Surgery News, Dr. Salgado attributed this increase in cell density to the effects of contact lens wear.

“Most of the patients were contact lens wearers for a long period, therefore, there is a lot of polymegathism and, most importantly, pleomorphism with lacunae among cells. When performing an endothelial cell count, those parameters, especially the lacunae, affect the result, giving an artificially low result,” he said.

“After implantation of this phakic IOL, the pleomorphism and polymegathism substantially reduce with consequent reduction of lacunae, allowing a less-biased counting, hence the higher cell density,” he said

Complications included mild iris precipitates in 12 eyes. They did not affect visual acuity, according to Dr. Salgado. Four eyes showed important iris pigment precipitates that resulted in a loss of two lines of BCVA. This regressed with oral steroids and mydriatics, he said.

“The complications of this IOL are mostly, if not exclusively, surgeon- related,” Dr. Salgado said.

Patient satisfaction was high, he said.

Surgical pearls

With a 6-mm optical zone, pupil size is not an issue with the Artiflex, according to Dr. Salgado, and compared with the previous version of the lens, the vault is higher, resulting in less contact between the iris and the lens.

Good iris fixation is achieved with implantation forceps designed by Ophtec that allow the surgeon to hold the lens by the haptics rather than by the optic, Dr. Salgado said.

Because the lens material is lightweight, Dr. Salgado said the surgeon needs only a small amount of iris tissue to enclavate the lens.

After the lens is secured in place, the surgeon may perform an iridectomy, a step some surgeons say is not necessary, Dr. Salgado said.

“I still do it to be on the safe side,” he said.

For more information:

Ramiro Salgado, MD, can be reached at Hospital da Arrábida, Praceta Henrique Moreira, 150, 4400-346 Vila Nova de Gaia, Gaia, Portugal; +351-223-776-800; fax: +351-223-776-899; e-mail: rsalgadoft@sapo.pt. He has no financial interest in the Artiflex phakic IOL.

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

Jared Schultz is an OSN Staff Writer who covers all aspects of ophthalmology. He focuses geographically on Europe and the Asia-Pacific region.