Correction of Moderate to High Myopia with a Foldable, Angle-Supported Phakic Intraocular Lens: Results from a 5-Year Open-Label Trial.

Objective: To evaluate the 5-year efficacy of a foldable, hydrophobic, angle-supported phakic intraocular lens (pIOL) when used to correct moderate to high myopia.

Methods: Prospective, nonrandomized, multicenter, open-label cohort study conducted in the United States, the European Union, and Canada (3 separate protocols). Methods: This was a pooled analysis of 515 eyes from 360 patients 18 to 49 years of age with moderate to high myopia (preoperative corrected distance visual acuity [CDVA] ≤0.34 logarithm of the minimum angle of resolution [logMAR]) and with variance in the manifest refraction spherical equivalent within ±0.5 diopter (D) for a minimum of 12 months. Methods: Implantation of the AcrySof Cachet angle-supported anterior chamber pIOL (Alcon Laboratories, Inc., Fort Worth, TX). Methods: Uncorrected distance visual acuity (UDVA), CDVA, predictability and stability of manifest refraction spherical equivalent (MRSE), serious adverse events, endothelial cell density, and patient satisfaction.

Results: Of 360 patients who received implantation in at least 1 eye (515 eyes), 326 (90.6%) completed the study (5-year best-corrected visual acuity data available for 415 eyes). At 5 years, a decrease in CDVA of 2 lines or more was observed in 0.5% of eyes (n = 2/415) compared with preoperative baseline. At 5 years, all 415 eyes achieved a CDVA of 0.34 logMAR or less; 91.3% (n = 379/415) had a CDVA of 0.04 logMAR or less. Mean UDVA ± standard deviation (SD) was 0.01±0.18 logMAR; 94.7% (n = 393/415) and 66.3% (n = 275/415) of eyes had a UDVA of 0.34 logMAR or less or 0.04 logMAR or less, respectively, at 5 years. Mean MRSE ± SD was -0.34±0.57 D (range,-2.50 to 1.63 D). Most eyes (89.8%; n = 371/413) had an MRSE within ±1.00 D of their target refractive error at 5 years and 67.3% (n = 278/413) were within ±0.50 D. Mean annualized central endothelial cell loss was 1.46% (90% confidence interval [CI], -1.6% to -1.3%) from 6 months to 5 years. The most common pIOL-related serious adverse event was adhesion between the cornea and the iris (synechia; n = 24). Most patients (98.1%) indicated that they would have the same pIOL implanted again.

Conclusions: In patients with moderate to high myopia, the AcrySof Cachet angle-supported pIOL provided excellent refractive correction for up to 5 years after implantation, with a low rate of mean central endothelial cell loss. Careful patient selection is necessary to achieve optimal postsurgical outcomes.