PURPOSE: To compare visual outcomes in patients with cataract surgery and bilateral implantation of a trifocal or bifocal intraocular lens (IOL). SETTING: University Eye Clinic Maastricht, the Netherlands. DESIGN: Prospective randomized clinical trial. METHODS:Eyes with cataract and less than 1.0 diopter (D) of corneal astigmatism were randomized to receive bilateral implantation of Finevision Micro F trifocal IOLs or Acrysof IQ Restor +3.0 bifocal IOLs. Outcome measures were monocular and binocular uncorrected distance (UDVA), uncorrected intermediate (UIVA), and uncorrected near (UNVA) visual acuities; refractive outcomes; binocular defocus curve; contrast sensitivity; reading speed; patient satisfaction; and spectacle independence. RESULTS: Six months postoperatively, the mean binocular UDVA, UIVA, and UNVA in 56 eyes of 28 patients were 0.01 logMAR ± 0.11 (SD), 0.32 ± 0.15 logMAR, and 0.15 ± 0.13 logMAR in the trifocal group (n = 15) and 0.00 ± 0.09 logMAR, 0.28 ± 0.08 logMAR, and 0.12 ± 0.08 logMAR in the bifocal group (n = 13), respectively. The trifocal group showed a more continuous defocus curve and better results at -1.0 D of defocus (P < .01). The mean mesopic contrast sensitivity was higher in the bifocal group (P = .02). Complete spectacle independence was reported by 80% of trifocal patients and 50% of bifocal patients. There were no significant differences in refractive outcomes, reading speed, or patient satisfaction. CONCLUSION: This study showed noninferiority of visual outcomes with the trifocal IOL compared with the bifocal IOL, although the defocus curve was better at an intermediate distance with the trifocal IOL. FINANCIAL DISCLOSURE: Dr. Bauer received study grants from Alcon Laboratories, Inc., Carl Zeiss Meditec AG, and Physiol S.A. and a lecture fee from Alcon Surgical, Inc. Dr. Nuijts is a consultant to Alcon Surgical, Inc., Théa Pharma GmbH, and ASICO LLC; he has received study grants from Acufocus, Inc., Alcon Surgical, Inc., Carl Zeiss Meditec AG, Ophtec BV, and Physiol S.A. No other author has a financial or proprietary interest in any material or method mentioned.
RCT Entities:
PURPOSE: To compare visual outcomes in patients with cataract surgery and bilateral implantation of a trifocal or bifocal intraocular lens (IOL). SETTING: University Eye Clinic Maastricht, the Netherlands. DESIGN: Prospective randomized clinical trial. METHODS: Eyes with cataract and less than 1.0 diopter (D) of corneal astigmatism were randomized to receive bilateral implantation of Finevision Micro F trifocal IOLs or Acrysof IQ Restor +3.0 bifocal IOLs. Outcome measures were monocular and binocular uncorrected distance (UDVA), uncorrected intermediate (UIVA), and uncorrected near (UNVA) visual acuities; refractive outcomes; binocular defocus curve; contrast sensitivity; reading speed; patient satisfaction; and spectacle independence. RESULTS: Six months postoperatively, the mean binocular UDVA, UIVA, and UNVA in 56 eyes of 28 patients were 0.01 logMAR ± 0.11 (SD), 0.32 ± 0.15 logMAR, and 0.15 ± 0.13 logMAR in the trifocal group (n = 15) and 0.00 ± 0.09 logMAR, 0.28 ± 0.08 logMAR, and 0.12 ± 0.08 logMAR in the bifocal group (n = 13), respectively. The trifocal group showed a more continuous defocus curve and better results at -1.0 D of defocus (P < .01). The mean mesopic contrast sensitivity was higher in the bifocal group (P = .02). Complete spectacle independence was reported by 80% of trifocal patients and 50% of bifocal patients. There were no significant differences in refractive outcomes, reading speed, or patient satisfaction. CONCLUSION: This study showed noninferiority of visual outcomes with the trifocal IOL compared with the bifocal IOL, although the defocus curve was better at an intermediate distance with the trifocal IOL. FINANCIAL DISCLOSURE: Dr. Bauer received study grants from Alcon Laboratories, Inc., Carl Zeiss Meditec AG, and Physiol S.A. and a lecture fee from Alcon Surgical, Inc. Dr. Nuijts is a consultant to Alcon Surgical, Inc., Théa Pharma GmbH, and ASICO LLC; he has received study grants from Acufocus, Inc., Alcon Surgical, Inc., Carl Zeiss Meditec AG, Ophtec BV, and Physiol S.A. No other author has a financial or proprietary interest in any material or method mentioned.
Authors: Ivo Ferreira-Ríos; Karla Zuñiga-Posselt; Juan Carlos Serna-Ojeda; Eduardo Chávez-Mondragón Journal: Int Ophthalmol Date: 2017-10-12 Impact factor: 2.031