This study examines long-term changes in endothelial cell density (ECD) in eyes implanted with Artisan (Ophtec BV) iris-fixated phakic intraocular lens (pIOL).

Study design

The authors measured ECD at baseline and 5 and 10 years in 127 eyes implanted with the Artisan Myopia pIOL and in 20 eyes implanted with the Artisan Toric pIOL.

Noncontact specular microscopy was performed using the same microscope for the entire 10-year period.

Outcomes

The mean ECD decreased by an average of 48 to 61 cells/mm² every year in a linear fashion, without any signs of plateau.

After correcting for estimated physiologic EC loss, total ECD decreased between 5% to 7.5% at 5 years, and by 11% to 16% at 10 years.

At 10 years, between 6.3% to 7.9% of eyes endured an EC loss of greater than 25% and approximately 4% had EC count of less than 1500 cells/mm². Criteria for suggested removal of an Artisan vary depending on the recommending entity, but include EC loss greater than 25% or EC count of less than 1,500 cells/mm². The explantation rate was approximately 5%.

Smaller eyes (shallower anterior chamber depth), smaller distance from the central pIOL edge to the endothelium, and smaller distance from the peripheral pIOL edge to the endothelium were significant risk factors affecting EC survival.

Limitations

The toric pIOL group had mean follow-up duration of only 50 months. Although it is a strength that the same specular microscope was used for the entire 10-year period, there is still significant variability in EC counting.

Clinical significance

Artisan iris-fixated phakic IOLs are associated with chronic EC loss. Patients require appropriate preoperative counseling and ongoing postoperative care. Surgeons should make sure to examine the anterior chamber depth and emphasize the importance of regular follow-up visits. The findings also suggest a higher preoperative age-related ECD threshold is needed to ensure that the cornea is healthy enough to endure future cataract extraction or pIOL explantation.