Long-term efficacy and safety profiles of iris-fixated foldable anterior chamber phakic intraocular lens implantation in eyes with more than 10 years of follow-up.

Purpose: To evaluate the long-term efficacy, safety, predictability, and stability of a foldable anterior chamber phakic intraocular lens (pIOL) (Artiflex) implantation in eyes with more than 10 years of follow-up.

Setting: Instituto de Microcirugía Ocular, Barcelona, Spain.

Design: Retrospective study.

Methods: Patients who underwent Artiflex pIOL implantation during 2008 to 2011 and with more than 10 years of follow-up were included. Variables analyzed were as follows: uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction, spherical equivalent (SE), endothelial cell count (ECC), and intraocular pressure (IOP) preoperatively and at 1 month, 1 year, 5 years, and the final follow-up. Descriptive statistics were performed and results reported following the Standard for Reporting Refractive Surgery Outcomes.

Results: 76 eyes (40 patients) were analyzed, and the mean follow-up was 10.67 ± 0.64 years. The mean preoperative SE was -8.26 ± 2.47 diopters (D), and the mean preoperative cylinder was -0.95 ± 0.86 D. At the final follow-up, efficacy and safety indices were 0.82 and 1.11, respectively. In total, 58 eyes (76%) achieved a UDVA of ≥20/40. 30 eyes (39%) gained ≥1 line of CDVA, and no eye lost ≥2 lines of CDVA. At the final follow-up, 46 (61%) and 58 (76%) eyes were within ±0.50 D and ±1.00 D of attempted SE correction, respectively. 72 eyes (95%) had ≤1.00 D of postoperative astigmatism, and 46 eyes (61%) were within ±15 degrees from the intended correction axis. At the last visit, a statistically significant myopic progression of -0.56 ± 0.83 D was observed ( P = .01). The mean ECC loss at the final follow-up was 12.2 ± 12.5%. IOP remained stable. Two eyes (2.63%) developed cataract after 10.3 years.

Conclusions: Long-term results demonstrated that Artiflex pIOL implantation was effective, predictable, stable, and safe.