High-addition segmented refractive bifocal intraocular lens in inactive age-related macular degeneration: A multicenter pilot study

PLoS One. 2021 Sep 2;16(9):e0256985. doi: 10.1371/journal.pone.0256985. eCollection 2021.

Abstract

This multicenter, open-label study aimed to determine the safety and functional outcome of a high-addition segmented refractive bifocal intraocular lens (IOL) in late inactive age-related macular degeneration (AMD). Twenty eyes of 20 patients were enrolled and followed until 12 months after the intervention. Patients underwent cataract surgery with implantation of a LS-313 MF80 segmented refractive bifocal intraocular lens with a near addition of +8.0 D (Teleon Surgical Vertriebs GmbH, Berlin, Germany). The main outcome measures were distance corrected near visual acuity (DCNVA) and safety as determined by intra- and post-operative complications. Secondary outcomes included distance corrected visual acuity (CDVA), uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), the need for magnification to read newspaper, preferred reading distance, speed and performance (logRAD), as well as patient satisfaction. Mean DCNVA improved from 0.95 (±0.19) to 0.74 (±0.35) logMAR, until 6 months after surgery, P<0.05. CDVA improved from 0.70 (±0.23) to 0.59 (±0.30) logMAR, UDVA from 0.94 (±0.25) to 0.69 (±0.34) logMAR, UNVA from 1.08 (±0.19) to 0.87 (±0.43) logMAR. The mean need for magnification decreased from 2.9- to 2.3-fold, preferred reading distance from 23 to 20 cm. No intraoperative complications occurred during any of the surgeries. One patient lost > 2 lines of CDVA between 6 and 12 months, in another case, the study IOL was exchanged for a monofocal one due to dysphotopsia and decreased CDVA. Implantation of a segmented refractive bifocal IOL with +8.0 D addition improves near and distance vision in patients with late AMD and has a satisfactory safety profile.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cataract Extraction / adverse effects*
  • Cataract Extraction / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Lens Implantation, Intraocular / adverse effects*
  • Lens Implantation, Intraocular / methods*
  • Lenses, Intraocular*
  • Macular Degeneration / diagnostic imaging
  • Macular Degeneration / surgery*
  • Male
  • Pilot Projects
  • Postoperative Complications
  • Prosthesis Design*
  • Reading
  • Refraction, Ocular
  • Tomography, Optical Coherence / methods
  • Treatment Outcome
  • Visual Acuity

Grants and funding

This study was funded by Oculentis/Teleon Surgical Vertriebs GmbH, Berlin, Germany, under the protocol number OCL/LS-313 MF80/02. GA receives funding from the Klaus Tschira Stiftung, Heidelberg, Germany. TY is funded by the Physician-Scientist Program of the Heidelberg University, Faculty of Medicine. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.