Thomas Reinhard1,2, Philip Maier3,4, Daniel Böhringer3,4, Eckart Bertelmann5, Tobias Brockmann5,6, Laszlo Kiraly7, David Salom8, Matteo Piovella9, Stephane Colonval10, Javier Mendicute11. 1. Klinik für Augenheilkunde, Universitätsklinikum Freiburg, Killianstrasse 5, 79106, Freiburg, Germany. thomas.reinhard@uniklinik-freiburg.de. 2. Medizinische Fakultät, Albert-Ludwigs-Universität Freiburg, Freiburg, Germany. thomas.reinhard@uniklinik-freiburg.de. 3. Klinik für Augenheilkunde, Universitätsklinikum Freiburg, Killianstrasse 5, 79106, Freiburg, Germany. 4. Medizinische Fakultät, Albert-Ludwigs-Universität Freiburg, Freiburg, Germany. 5. Charité - Universitätsmedizin, Berlin, Germany. 6. Universitätsmedizin, Rostock, Germany. 7. Augenlaserzentrum, Leipzig, Germany. 8. Hospital de Manises, Valencia, Spain. 9. Centro Microchirurgia Ambulatoriale, Monza, Italy. 10. Centre Hospitalier Jolimont Lobbes, Binche, Belgium. 11. Hospital Universitario, Donostia, Spain.
Abstract
PURPOSE: The AT LARA 829MP is a next-generation extended depth of focus (EDOF) intraocular lens (IOL) providing continuous vision over a range of distances. The aim of this prospective multi-centre randomised trial was to compare two EDOF IOLs and one monofocal IOL. METHODS:Cataract patients between 50 and 80 years were randomised for bilateral implantation with either the AT LARA 829MP (EDOF), the TECNIS Symfony (EDOF) or the CT ASPHINA 409MP (monofocal). Follow-up was at 1 to 2 weeks, 1 month and 4 to 6 months. RESULTS:A total of 211 patients were randomised and included in the final analysis. Monocular depth of focus was significantly better for AT LARA 829MP eyes compared with that for TECNIS Symfony at all thresholds (p = 0.024, 0.001 and 0.006, for 0.1, 0.2 and 0.3 logMAR respectively) with no significant difference for binocular depth of focus. LARA eyes had significantly better monocular depth of focus at all levels compared with ASPHINA eyes (all p < 0.0001), while there was no significant difference between Symfony and ASPHINA eyes at 0.1 logMAR and 0.2 logMAR. Both EDOF IOLs were significantly better than the monofocal ASPHINA at all levels for binocular depth of focus (LARA: all p < 0.0001; Symfony: all p = 0.002). Distance visual acuity was similar for all IOLs at 6 months; intermediate and near visual acuity were significantly better for the EDOF IOLs than for the monofocal (p < 0.0001). Refraction improved in all groups relative to baseline. Contrast sensitivity was higher with the CT ASPHINA 409MP but both EDOF lenses had a better spectacle independence rate. At 6 months, all IOLs were well centred with no cases of tilt. No general safety issues were raised for any of the groups. CONCLUSION: The two EDOF intraocular lenses investigated provided good visual outcomes with comparable visual acuity at all distances. The AT LARA 829MP provided the widest monocular depth of focus at 0.1 and 0.2 logMAR, with a clear superiority compared with the monofocal IOL. TECNIS Symfony was superior to the monofocal control at 0.3 logMAR. Spectacle independence and patient satisfaction were comparable. TRIAL REGISTRATION: Trial registered on https://clinicaltrials.gov/ under the identification NCT03172351 (date of registration 1 June May 2017).
RCT Entities:
PURPOSE: The AT LARA 829MP is a next-generation extended depth of focus (EDOF) intraocular lens (IOL) providing continuous vision over a range of distances. The aim of this prospective multi-centre randomised trial was to compare two EDOF IOLs and one monofocal IOL. METHODS:Cataractpatients between 50 and 80 years were randomised for bilateral implantation with either the AT LARA 829MP (EDOF), the TECNIS Symfony (EDOF) or the CT ASPHINA 409MP (monofocal). Follow-up was at 1 to 2 weeks, 1 month and 4 to 6 months. RESULTS: A total of 211 patients were randomised and included in the final analysis. Monocular depth of focus was significantly better for AT LARA 829MP eyes compared with that for TECNIS Symfony at all thresholds (p = 0.024, 0.001 and 0.006, for 0.1, 0.2 and 0.3 logMAR respectively) with no significant difference for binocular depth of focus. LARA eyes had significantly better monocular depth of focus at all levels compared with ASPHINA eyes (all p < 0.0001), while there was no significant difference between Symfony and ASPHINA eyes at 0.1 logMAR and 0.2 logMAR. Both EDOF IOLs were significantly better than the monofocal ASPHINA at all levels for binocular depth of focus (LARA: all p < 0.0001; Symfony: all p = 0.002). Distance visual acuity was similar for all IOLs at 6 months; intermediate and near visual acuity were significantly better for the EDOF IOLs than for the monofocal (p < 0.0001). Refraction improved in all groups relative to baseline. Contrast sensitivity was higher with the CT ASPHINA 409MP but both EDOF lenses had a better spectacle independence rate. At 6 months, all IOLs were well centred with no cases of tilt. No general safety issues were raised for any of the groups. CONCLUSION: The two EDOF intraocular lenses investigated provided good visual outcomes with comparable visual acuity at all distances. The AT LARA 829MP provided the widest monocular depth of focus at 0.1 and 0.2 logMAR, with a clear superiority compared with the monofocal IOL. TECNIS Symfony was superior to the monofocal control at 0.3 logMAR. Spectacle independence and patient satisfaction were comparable. TRIAL REGISTRATION: Trial registered on https://clinicaltrials.gov/ under the identification NCT03172351 (date of registration 1 June May 2017).
Entities:
Keywords:
Cataract, presbyopia; Defocus; Depth of focus; EDOF; Intermediate visual acuity; Near visual acuity
Authors: Daniel T Hogarty; Deborah J Russell; Bernadette M Ward; Nicholas Dewhurst; Peter Burt Journal: Clin Exp Ophthalmol Date: 2018-05-21 Impact factor: 4.207
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Authors: José F Alfonso; Luis Fernández-Vega; M Begoña Baamonde; Robert Montés-Micó Journal: J Cataract Refract Surg Date: 2007-07 Impact factor: 3.351