Long-term efficacy and safety results after iris-fixated foldable phakic intraocular lens for myopia and astigmatism: 6-year follow-up

Abstract

Purpose: To evaluate the long-term efficacy and safety of iris-fixated foldable phakic intraocular lenses (pIOLs) for the management of myopia and astigmatism after 6-year follow-up. Setting: Ophthalmology Department, Hospital Braga, Portugal. Design: Retrospective cohort study. Methods: Patients included underwent iris-fixated foldable Artiflex pIOL implantation between January 2010 and December 2013. Follow-up evaluations were performed 6 months postoperatively and every 12 months until 72 months. Preoperative and follow-up data on uncorrected and corrected distance visual acuity (CDVA), manifest refraction, endothelial cell density (ECD), and anterior chamber depth (ACD) were analyzed. Results: A total of 177 eyes of 98 patients with a mean age of 32.33 ± 7.13 years were analyzed. There was a statistically significant improvement in CDVA from 0.09 ± 0.02 logMAR preoperatively to 0.04 ± 0.02 logMAR (P < .0001) at 6 years postoperatively. The spherical equivalent demonstrated a statistically significant improvement from −9.50 ± 2.93 diopters (D) to −0.41 ± 0.45 D at 6 years. At 72 months, the efficacy and safety indexes were 0.94 and 1.15, respectively. A mean loss of 31.77 cells/mm2 (1.19%) was observed each year until the sixth year. The overall mean ECD loss after correction for the physiological loss was 3.02% after 6 years. No correlations were observed between the mean ECD loss and the preoperative ACD. Conclusions: The Artiflex pIOL was a safe, effective, and a stable option to correct myopia. A mean ECD loss of 3.02% was observed over 6 years. No pIOL was explanted due to corneal decompensation.

Myopic Correction with Iris-Fixated Phakic Intraocular Lenses: Twelve-Year Results

“…Our results are in good agreement with other studies which showed successful refractive results of IF pIOLs implantation [ 7 , 10 , 11 , 14 , 23 , 24 ]. Tahzib et al reported the MRSE −0.7 ± 1.0 D after 10 years, with no significant change in MRSE between 1, 6, and 10 years.…”

“…In keeping with the literature, we did not find any long-term statistical change of intraocular pressure after surgery [ 5 , 10 , 14 , 24 , 27 ].…”

“…UDVA 20/40 or better was reached in 82% of eyes, BDVA 20/40 or better in 93.3% of eyes, and only 2.6% of eyes lost more than 2 Snellen lines of BDVA [ 10 ]. Monteiro et al calculated 6-year post-IF pIOL implantation EI and SI, 0.94 and 1.15, respectively [ 24 ]. Jonker et al mentioned the mean myopization −0.79 D over 10 years after surgery.…”

“…Baikoff et al and others reported the occurrence of pigment dispersion typically in hyperopic eyes [ 14 , 25 ]. On the opposite side, Monteiro et al found pigment precipitates in 10.17% of myopic eyes in the early postoperative period and treated them successfully with topical steroids [ 24 ]. We did not register any case of pigment dispersion in our myopic group of patients.…”

“…On the contrary, Jonker et al wrote about fluctuating ACD rising from greater accommodative capacity in younger patients [ 9 ]. But in the end, no author proved the impact of age on long-time EC loss after the IF pIOLs implantation [ 6 , 9 , 10 , 15 , 24 ].…”