Long-Term Outcomes of Iris-Fixated Phakic Intraocular Lenses in Low Myopia: A Retrospective Analysis With Over a Decade of Follow-up

Purpose

To evaluate the clinical indications and long-term outcomes—specifically efficacy, safety, predictability, and stability—of iris-fixated anterior chamber phakic intraocular lenses (pIOLs) in patients with low myopia spherical equivalent (SE) <–6.00 diopters (D).

Design

Retrospective, single-center case series.

Subjects

A total of 155 eyes from 96 patients with SE < –6.00 D underwent implantation with either Artisan or Artiflex pIOLs between 2009 and 2019. For long-term analysis, only eyes without prior intraocular surgery that received Artiflex lenses were included (n = 103).

Methods

Preoperative and annual postoperative assessments included uncorrected (UDVA) and corrected distance visual acuity (CDVA); efficacy index (postoperative UDVA/preoperative CDVA) and safety index (postoperative CDVA/preoperative CDVA); manifest refraction, SE, endothelial cell density (ECD), and intraocular pressure (IOP). Clinical indications for implantation were recorded. Descriptive statistics were conducted.

Main Outcome Measures

Frequency of clinical indications for implantation, visual acuity (UDVA, CDVA), manifest refraction including SE and astigmatism, refractive predictability and long-term stability, ECD, IOP, and incidence of adverse events.

Results

The mean preoperative SE was –4.64 ± 0.92 D and cylinder –0.86 ± 0.76 D. The average follow-up was 6.55 ± 4.08 years (range, 1-15 years). Topographic alterations (40.4%), central corneal thickness <500 µm (21.1%), and stable keratoconus (8.5%) were the most common indications. At final follow-up, 71% and 87% of eyes were within ±0.50 D and ±1.00 D of the attempted SE correction, respectively. Postoperative astigmatism was <1.00 D in 93% of eyes. Efficacy and safety indices were 0.90 and 1.02 at 1 year and remained stable over time (P = .140 and P = 1.000, respectively). The mean annual ECD loss was 38.6 cells/mm²/y, corresponding to an annualized percentage loss of 1.11%. IOP remained stable throughout follow-up. Four eyes (2.58%) required IOL explantation.

Conclusions

Over more than 10 years of follow-up, long-term results indicate that Artiflex pIOL implantation is effective, predictable, stable, and safe in patients with low myopia <–6 D of SE.