PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.