When Is It Time to Remove a Phakic IOL?

Corneal decompensation caused by phakic IOLs may severely jeopardize surgical outcomes, especially DMEK, suggesting a timely explantation as the best solution. According to Rudy Nuijts MD, PhD, the phenomena of corneal endothelial cell loss years after phakic IOL implantation is well known. Citing a previous study, Professor Nuijts observed how the most prominent outcome was the nine-year average between lens implantation and detection of significant cell loss.¹

“In the beginning, everything is fine, and you really have to wait for a long time before seeing significant negative effects,” he said.

The decision to suspend the I-CARE phakic IOL from the market in March 2007 prompted the French government to issue a rule dictating that every phakic IOL that causes a loss of endothelial cells higher than 25% or a density under 1,500 cells per square millimetre should be explanted as soon as possible. This position was later adopted by the FDA in the United States, making it a globally accepted guideline.

So, what about endothelial cell loss in rigid iris fixation IOLs, such as the Artisan? In an effort to answer this question, Prof Nuijts performed an 18-year study, from January 1998 to June 2016, on 507 eyes from 289 patients who received a myopic or toric iris-fixated PIOL implant at the University Eye Clinic Maastricht in the Netherlands. Reviewing the 6-month to 10-year postoperative data, the proportional cell loss of the Artisan myopia and toric lenses was 16.6% and 21.5% (respectively) and 10.9% and 15.8% (respectively) when corrected with the physiological 0.6% yearly loss. Such rates were two to three times higher than would be seen physiologically, he observed.²

However, only 1% of patients had the lens explanted before the 10-year threshold, rapidly increasing to 6% in the study over the complete follow-up, with a mean time of explantation set at 12 years. The indications were cataract surgery with pooled endothelial-related causes accounting for 6% of cases. The authors observed a similar drop in the survival curve after 10 years in a complementary 8-year prospective clinical cohort study on foldable iris-fixated PIOLs, with the Artisan hyperopia group being the most susceptible to explantation due to endothelial cell loss.³

As for the ICL, a 2019 study showed a cell loss rate of 5.3% at 10 years, lower than the iris-fixated PIOL, but still high compared to the physiological rate, Prof Nuijts observed.⁴

A bilensectomy, namely lens removal combined with phacoemulsification, should be the first option if the cell count is higher than 1,500 per square millimetre, he suggested.

Despite some short-term benefits, patients in the literature with an ongoing corneal decompensation who were treated with DMEK scored an endothelial cell loss of 39.9% at 12 months postoperatively and up to 55.6% at year 2 and 62% at 4 years. The endothelial cell loss after a cumbersome surgery as DMEK is quite extensive, he observed.

However, time is of the essence to avoid irreversible damage. “If you have to perform a DMEK in this scenario, you will lose almost half of the cells in one year with related issues, such as IOL calculation errors, swollen cornea, and limited corneal visualisation,” Prof Nuijts explained.

“Check the endothelial cell status every year postoperatively and before you [perform] surgery on these patients and explant the lens using the parameters of 25% loss or 1,500 cells per square millimetre [as a] threshold.”

Dr Nuijts spoke at the 2025 ESCRS Winter Meeting in Athens.

Rudy MMA Nuijts MD, PhD is Professor of Ophthalmology and Director of the Cornea Clinic Center for Refractive Surgery at the University Eye Clinic Maastricht, Maastricht University Medical Center (MUMC), Netherlands. rudy.nuijts@mumc.nl

1. Alió JL, et al. Ophthalmology, 2006 Dec; 113(12): 2213–2220.

2. Jonker SMR, et al. Ophthalmology, 2018 Apr; 125(4): 486–494.

3. Jonker SMR, et al. Am J Ophthalmology, 2018 Oct; 194: 110–119.

4. Nakamura T, et al. Am J Ophthalmology, 2019 Oct; 206: 1–10.