First Results Of A Confirmatory Multicentre Study With The Lumina Presbyopia Correcting Intraocular Lens In The Netherlands And Germany
Published 2024 - 42nd Congress of the ESCRS
Reference: FP10.03 | Type: Free paper | DOI: 10.82333/kk8h-b081
Authors: Stefan Coppens* 1 , Jens Schrecker 2 , Youssef Botros 3 , Eckhard Becker 4 , Jeroen Beerthuizen 5 , Monika Landesz 6 , Nic Reus 7 , Timo Eppig 8
1Xpert Clinics Oogzorg,Zeist,Netherlands, 2Rudolf-Virchow-Klinikum,Glauchau,Germany, 3Viselle Augenzentrum,Erlangen,Germany, 4Augentagesklinik Oranienburg,Oranienburg,Germany, 5RKZ EyeScan,Beverwijk,Netherlands, 6EyeScan Utrecht,Utrecht,Netherlands, 7Amphia Ziekenhuis,Breda,Netherlands, 8Amiplant Gmbh,Schnaittach,Germany
Purpose
The aim of this post marketing study is to evaluate the optical and patient reported outcomes of patients implanted with an innovative presbyopia correcting intraocular lens (IOL) (Lumina by AkkoLens International B.V.) and to confirm that results from earlier clinical studies in Bulgaria, Spain and Colombia can be repeated in a wider setting and in routine clinical practice. The Lumina is a dual-optic sulcus based hydrophilic IOL that changes lens power when driven by the ciliary muscle. The Lumina is designed to provide a change in optical power of over 3D while maintaining contrast sensitivity and optical quality as in a monofocal IOL.
Setting
Xpert Clinics Oogzorg Zeist (NL), RKZ EyeScan Beverwijk (NL), Amphia Ziekenhuis Breda (NL), EyeScan Utrecht (NL), Augentagesklinik Oranienburg MVZ (D), Rudolf Virchow Klinikum Glauchau (D), Viselle Augenzentrum Erlangen (D)
Methods
A longitudinal multicentre post marketing clinical study. Seven clinics in Germany, and The Netherlands are participating in this study which aims to include 140 patients. Patients with bilateral cataract and a desire to achieve spectacle independence are implanted with the Lumina IOL bilaterally.
Patients receive a complete optometric and ophthalmologic examination before and after surgery including measurement of visual acuity, contrast sensitivity, defocus curve and objective accommodation measurement by an open field autorefractor. Patient satisfaction is assessed with the aid of questionnaires. The follow-up evaluation is between 3 and 24 months. This paper is an interim report.
Results
Results of the first 25 implants are included. Mean monocular uncorrected distance visual acuity was 0.09 ± 0.11, mean monocular corrected distance visual acuity was -0.04 ± 0.07; mean monocular distance corrected intermediate visual acuity was 0.10 ± 0.08; mean monocular distance corrected near visual acuity (DCNVA) was 0.22 ± 0.21; mean binocular DCNVA was 0.10 ± 0.10 (all VA LogMAR).
72% of eyes was within 0.5D of target. Mean cylinder pre-op was -0.76 ± 0.29D versus post-op -0.74 ± 0.52D and -0.53 ± 0.50D respectively at 1 week and 1 month follow-up.
Mean pre-op IOP was 17.8 ± 3.5 mm Hg. No significant IOP elevation was observed after surgery.
Measurements (PowerRef3 autorefractor) indicate a lens power change up to 2.5D.
Conclusions
The Lumina IOL is now being implanted in seven clinics in Germany and The Netherlands and interim results are confirming the findings of earlier studies. The Lumina IOL is implanted in a routine cataract surgery procedure. Incision size in all implants is below 3.0 mm. Implanting the Lumina does not induce additional astigmatism and the refractive predictability is good.
These findings further confirm that the Lumina is a promising presbyopia correcting IOL and seems to provide a significant level of spectacle independence without the well-known side effects of multifocal IOLs. Data and results will be further complemented at the completion of the multicentre study.