Laura Gasser1, Julia Biermann2, Thomas Reinhard2. 1. From the Eye Center, University Hospital Freiburg, Freiburg, Germany. Electronic address: laura.gasser@uniklinik-freiburg.de. 2. From the Eye Center, University Hospital Freiburg, Freiburg, Germany.
Abstract
PURPOSE: To present the 3-year results regarding the safety and efficacy of the Epi.Lens N, a new posterior chamber phakic intraocular lens (PC pIOL). SETTING: Eye Center, University Hospital Freiburg, Freiburg, Germany. DESIGN: Prospective clinical study. METHODS: A PC pIOL was implanted in highly myopic eyes of consecutive patients. Standardized follow-up examinations including uncorrected (UDVA) and corrected (CDVA) distance visual acuities and refractions were performed 1, 3, and 6 months and 1, 2, and 3 years postoperatively. RESULTS: The patient cohort consisted of 30 eyes of 16 patients. The study eyes had a mean manifest refraction spherical equivalent of -10.1 diopters (D) ± 3.4 (SD), which decreased to -0.3 ± 0.8 D postoperatively. After 3 years, all eyes achieved (47%) or exceeded (53%) their preoperative CDVA, thus improving the mean CDVA from 20/21 (0.94) preoperatively to 20/18 (1.14) postoperatively. The mean postoperative UDVA (20/20 [0.98]) resembled the preoperative CDVA (20/21 [0.94]). When analyzing all eyes with good visual potential (preoperative CDVA 20/20 or better; n = 18), 94% achieved a postoperative UDVA of 20/20 or better. One small-diameter PC pIOL contacted the crystalline lens, which led to slight anterior subcapsular lens opacification. Despite this, the patient achieved a CDVA of 20/20. CONCLUSION: The 3-year results of this pilot study of a new PC pIOL showed good efficacy and safety. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.
PURPOSE: To present the 3-year results regarding the safety and efficacy of the Epi.Lens N, a new posterior chamber phakic intraocular lens (PC pIOL). SETTING: Eye Center, University Hospital Freiburg, Freiburg, Germany. DESIGN: Prospective clinical study. METHODS: A PC pIOL was implanted in highly myopic eyes of consecutive patients. Standardized follow-up examinations including uncorrected (UDVA) and corrected (CDVA) distance visual acuities and refractions were performed 1, 3, and 6 months and 1, 2, and 3 years postoperatively. RESULTS: The patient cohort consisted of 30 eyes of 16 patients. The study eyes had a mean manifest refraction spherical equivalent of -10.1 diopters (D) ± 3.4 (SD), which decreased to -0.3 ± 0.8 D postoperatively. After 3 years, all eyes achieved (47%) or exceeded (53%) their preoperative CDVA, thus improving the mean CDVA from 20/21 (0.94) preoperatively to 20/18 (1.14) postoperatively. The mean postoperative UDVA (20/20 [0.98]) resembled the preoperative CDVA (20/21 [0.94]). When analyzing all eyes with good visual potential (preoperative CDVA 20/20 or better; n = 18), 94% achieved a postoperative UDVA of 20/20 or better. One small-diameter PC pIOL contacted the crystalline lens, which led to slight anterior subcapsular lens opacification. Despite this, the patient achieved a CDVA of 20/20. CONCLUSION: The 3-year results of this pilot study of a new PC pIOL showed good efficacy and safety. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.