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.