Pilot Study of a New Posterior Chamber Phakic Intraocular Lens (Epi.Lens) for High Myopia

Abstract

To report the first safety and efficacy results of a new posterior chamber phakic intraocular lens (PIOL) (Epi.Lens, Acri.Tec/Carl Zeiss Meditec) implanted in the ciliary sulcus to correct high myopia. The Epi.Lens was implanted for the first time in 48 consecutive eyes of 25 patients in an ongoing two-center clinical study. Pre- and postoperative manifest refraction, uncorrected (UDVA) and corrected distance visual acuity (CDVA), intraocular pressure, slit-lamp and funduscopic examination, and ultrasound biomicroscopy were evaluated. Follow-up examinations were performed at 1, 3, 6, 12, and 24 months postoperatively. For each patient, the latest follow-up data were considered. The study cohort consisted of highly myopic patients with mean preoperative manifest refraction spherical equivalent of -9.90 ± 2.53 D, which was reduced to -0.26 ± 0.84 D postoperatively. Two (4.2%) eyes lost one line of CDVA postoperatively, whereas 19 (40%) met and 27 (56%) eyes exceeded preoperative CDVA values, thus improving mean CDVA from 0.83 ± 0.30 to 1.03 ± 0.26. Mean postoperative UDVA (0.85 ± 0.37) was similar to preoperative CDVA (0.83 ± 0.30). When considering all eyes with good visual potential (preoperative CDVA ≥ 1.00 [20/20] [n=25]), 20 (80%) achieved postoperative UDVA ≥ 1.00 (20/20), and 24 (96%) achieved UDVA ≥ 0.80 (20/25). One lens with a small diameter showed contact of the Epi.Lens and crystalline lens with subsequent slight anterior subcapsular cataract; however, CDVA was 1.00 (20/20) at last follow-up 2 years postoperatively. The results of this Epi.Lens pilot study demonstrate good safety and efficacy. The preliminary data are encouraging, and longer follow-up results are anticipated.