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

PURPOSE

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

DESIGN

Prospective, nonrandomized, multicenter, open-label cohort study conducted in the United States, the European Union, and Canada (3 separate protocols).

PARTICIPANTS

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.

INTERVENTION

Implantation of the AcrySof Cachet angle-supported anterior chamber pIOL (Alcon Laboratories, Inc., Fort Worth, TX).

MAIN OUTCOME MEASURES

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.