Remember me
The use of a monofocal intraocular lens (IOL) is considered as the standard of care (SoC) in cataract surgery in terms of the IOL to implant (Supplementary Material, available at https://links.lww.com/JRS/B141). The main reason for this widely accepted statement is that this was the first type of IOL developed.1 However, a specific mode of proceeding in healthcare can be considered as SoC when some specific conditions are met: (1) agreement with local and national legal regulations; (2) agreement with authoritative clinical guidelines: clinical care standards, preferred practice patterns, clinical practice guidelines, or standard treatment guidelines; (3) agreement with professional guidelines: clinical care standards, preferred practice patterns, clinical practice guidelines, standard treatment guidelines, and consensus documents; (4) support from professional organizations: position papers, statements, and consensus documents; And (5) scientific evidence: clinical and patient-reported outcomes and cost-effectiveness studies.2,3
To this date, there are different guidelines and statements on cataract surgery, but no recommendation regarding the selection of the IOL to implant is provided in any of them. Indeed, there are no authoritative clinical or professional guidelines on how to select the type of IOL to implant. However, advances in IOL optics have been introduced in past few years, leading to a more optimized visual rehabilitation after cataract surgery, such as the development of enhanced monofocal IOLs, that are also designated in some contexts as monofocal plus IOLs.4,5 These enhanced monofocal IOLs include some optical modifications to provide an efficacious correction for distance vision while providing an enhanced intermediate visual function. This full distance vision combined with an improved intermediate vision can be enough to provide the patients with a functional vision, allowing overcoming most of their limitations in terms of activities of daily living.6 These modified monofocal IOLs do not fully meet 1 or more effectiveness end points that should be met according to the American National Standard Institute Z80.35-2018 for classifying them as extended depth-of-focus (EDOF) IOLs: (1) To demonstrate a statistical superiority over a control monofocal group on mean, monocular photopic distance-corrected intermediate visual acuity at 66 cm. (2) To demonstrate at least 0.5-diopter greater monocular photopic negative lens induced distance-corrected depth of focus compared with the monofocal control IOL at 0.2 logMAR visual acuity threshold. (3) The median monocular distance-corrected photopic intermediate visual acuity at 66 cm must be at least 0.2 logMAR. (4) The mean monocular photopic best corrected distance acuity for the EDOF IOL must be statistically noninferior to the control monofocal group using a noninferiority margin of 0.1 logMAR.7,8
Considering the potential superiority of enhanced monofocal IOLs over conventional monofocal IOLs in terms of intermediate visual acuity and the equivalence between IOL types in terms of safety, the use of these enhanced monofocal IOLs as SoC in cataract surgery should be discussed. For this purpose, the first step is to confirm whether there is enough scientific evidence confirming the clinical superiority of enhanced monofocal over conventional monofocal IOLs. It should be considered that the level of bias and the consistency of such evidence are critical to establish clinical recommendations. Randomized clinical trials (RCTs) and meta-analysis of RCT data are the gold standard for evaluating the safety and effectiveness of an intervention, providing the highest quality level I evidence according to the hierarchy of evidence defined by the Oxford Centre for Evidence-Based Medicine.9 The purpose of this special report was to evaluate the scientific evidence of the use of enhanced monofocal IOL implantation in cataract surgery in comparison with monofocal IOL visual performance.
A literature review was performed on PubMed, Scopus, and Web of Science to analyze the level of scientific evidence on enhanced monofocal IOLs. A search equation was conducted in PubMeD (date May 31, 2023, revised March 22, 2023) with the following terms related to the several types of enhanced monofocal IOLs according to Fernandez et al. (2023) and the latest developments: Acunex or Lentis QUANTUM (Teleon Surg.); EVOLUX (Sifi Medtech Srl); Extend HP (Hanita Lenses); TECNIS Eyhance (Jonhson & Jonhson Vision); IsoPure (Physiol S.A.); RayOne EMV (Rayner Intraocular Lenses Ltd.); Vivinex Impress (Hoya Corp.); Xact ME4 (Santen GmbH); ZOE (OphthalmoPro GmbH); and Aspire (Bausch & Lomb, Inc.).5
Search results showed a total of 3 reviews and 66 articles from the primary literature ranging from 2020 to 2024. Screening of abstracts resulted in the exclusion of 28 publications not meeting the main purpose, that is, studies not comparing conventional monofocal with enhanced monofocal IOLs (N = 22), studies evaluating the clinical outcomes of enhanced monofocal IOLs in pathological eyes (N = 2), research studies in which the visual performance analysis was not the main purpose (N = 3), or investigations in which the visual performance was not measured under standard conditions (N = 1). In addition, 12 publications referred to in vitro measurements on the optical bench. Finally, a total of 1 meta-analysis and systematic review, 1 meta-analysis, 1 scoping review, and 19 clinical studies were considered for analysis (Table 1).5,10–34
Table 1. - List of peer-reviewed publications analyzed Study Study type IOLs (enhanced monofocal vs monofocal) Follow-up Summary of VA results (enhanced monofocal vs monofocal, P value) Giglio et al. (2024)12 Randomized clinical trial Eyhance ICB00 vs TECNIS PCB00 or Clareon CNA0T0 3 mo Bino UDVA: −0.03 ± 0.07 vs −0.05 ± 0.06 (P = .259)In summary, most of the studies reviewed confirmed the superiority of enhanced monofocal IOLs in terms of intermediate visual function over conventional monofocal IOLs, with a maximum level of scientific evidence associated (level Ia) (Table 2). This maximum level has been achieved because several RCTs have supported these findings, being summarized and evidenced in systematic reviews and meta-analyses of such trials. This enhanced intermediate visual function was reached with no distance visual acuity worsening or contrast sensitivity or visual quality deterioration associated. Therefore, enhanced monofocal IOLs provide interchangeable results in terms of distance vision compared with conventional monofocal IOLs.12–34
Table 2. - Summary of the type of scientific evidence available on enhanced monofocal IOLs Evidence N Funding Conflict of interest Meta-analysis 2 — — Systematic reviews 2 — — Randomized controlled trial 7 Giglio et al.12: Unrestricted grant of the IOL company None Ang et al.15: Funded by Beaver-Visitec International, Inc. Grants and personal fees from the IOL company Goslings et al.17: Unrestricted grant of the IOL company None Pérez-Sanz et al.18: No funding None Choi et al.20: Funded by Medical Research Funds from Kangbuk Samsung Hospital None Garzón et al.21: Unrestricted grant of the IOL company None Auffharth et al.29: Funded by the IOL company Grants and personal fees from the IOL companyMost of the clinical studies reviewed were focused on the analysis of the functional results obtained with enhanced and conventional monofocal IOLs, including meaningful metrics that affect patients and, even in some cases, patient-reported outcomes measured with validated questionnaires.17 All these results are critical for taking the relevant decision of implanting the enhanced and conventional models of monofocal IOLs. Contrarily, optical bench testing should not be used for clinical decision-making as they do not necessarily reflect the actual behavior in patients, although they can serve as informative about the potential optical behavior of the optics.
According to our review, the first condition for establishing the use of enhanced monofocal IOLs as SoC in cataract surgery is accomplished. However, cost-effectiveness studies are still needed and highly recommended to demonstrate that the clinical benefit obtained with enhanced monofocal IOLs is greater than the cost increase compared with conventional monofocal IOLs. In addition, position papers or consensus statements from different eyecare professional organizations are needed to give visibility to the benefit of enhanced monofocal IOLs based on the results of the clinical studies revised. In the future, these documents and data can be used to show the relevance of this potential new SoC in cataract surgery to public institutions.
1. Binkhorst CD. Ridley's intraocular lens prothesis; the postoperative reaction; results obtained in 12 cases. Ophthalmologica 1957;133:384–392 2. Vanderpool D. The standard of care. Innov Clin Neurosci 2021;18:50–51 3. Cooke B, Worsham E, Reiseld G. The elusive standard of care. J Am Acad Psychiatry Law 2017;45:358–364 4. Kanclerz P, Toto F, Grzybowski A, Alio JL. Extended depth-of-field intraocular lenses: an update. Asia Pac J Ophthalmol (Phila) 2020;9:194–202 5. Fernández J, Rocha-de-Lossada C, Zamorano-Martín F, Rodríguez-Calvo-de-Mora M, Rodríguez-Vallejo M. Positioning of enhanced monofocal intraocular lenses between conventional monofocal and extended depth of focus lenses: a scoping review. BMC Ophthalmol 2023;23:101 6. Ribeiro F, Cochener B, Kohnen T, Mencucci R, Katz G, Lundstrom M, Casanovas AS, Hewlett D. Definition and clinical relevance of the concept of functional vision in cataract surgery ESCRS position statement on intermediate vision: ESCRS Functional Vision Working Group. J Cataract Refract Surg 2020;46:S1–S3 7. American National Standard for Ophthalmics. ANSI Z80.35-2018: extended depth of focus intraocular lenses. 2018. Available at: https://webstore.ansi.org/standards/vc%20(asc%20z80)/ansiz80352018. Accessed March 3, 2023 8. Kohnen T, Suryakumar R. Extended depth-of-focus technology in intraocular lenses. J Cataract Refract Surg 2020;46:298–304 9. Howick J, Chalmers I, Glasziou P, Greenhalgh T, Heneghan C, Liberati A, Moschetti I, Phillips B, Thornton H. Explanation of the 2011 Oxford Centre for Evidence-Based Medicine (OCEBM) Levels of Evidence (Background Document). Oxford Centre for Evidence-Based Medicine. Last Updated: 2011. REF2023OTH4332. Available at: https://www.cebm.ox.ac.uk/resources/levels-of-evidence/explanation-of-the-2011-ocebm-levels-of-evidence/. Accessed February 24, 2023 10. Redruello-Guerrero P, Rivera-Izquierdo M, Jiménez-Gutiérrez C, Láinez-Ramos-Bossini AJ, Yela R, López-Marín I. Improvement of intermediate vision with new monofocal intraocular lenses: a systematic review and meta-analysis. Eur J Ophthalmol 2023;33:1308–1319 11. Wan KH, Au ACK, Kua WN, Ng ALK, Cheng GPM, Lam NM, Chow VWS. Enhanced monofocal versus conventional monofocal intraocular lens in cataract surgery: a meta-analysis. J Refract Surg 2022;38:538–546 12. Giglio R, Vinciguerra AL, Presotto M, Jonak K, Rejdak R, Toro MD, Nanavaty MA, Tognetto D. Visual outcomes and patient satisfaction after bilateral implantation of an enhanced monofocal intraocular lens: a single-masked prospective randomized study. Int Ophthalmol 2024;44:112 13. Singh G, Sidhharthan KS, Reddy JK, Sundaram V, Thulasidas M. Comparison of visual outcomes in patients implanted with Tecnis Eyhance ICB00 and 1-Piece ZCB00 monofocal intraocular lenses. Indian J Ophthalmol 2024;72:181–184 14. Negishi K, Masui S, Ayaki M, Torii H, Yotsukura E, Nishi Y. Clinical results and factors affecting visual function in eyes implanted with an enhanced monofocal intraocular lens. Clin Ophthalmol 2023;17:3965–3973 15. Ang RET, Stodulka P, Poyales F. Prospective randomized single-masked study of bilateral isofocal optic-design or monofocal intraocular lenses. Clin Ophthalmol 2023;17:2231–2242 16. Gigon E, Bouthour W, Panos GD, Pajic B, Massa H. Real world outcomes of the new Tecnis Eyhance IOL. Eur J Ophthalmol 2023;33:1390–1397 17. Goslings O, Veraart H, van de Laar-Muskens J, Piñero DP. Clinical outcomes with an aspheric monofocal and a new enhanced monofocal intraocular lens with modified optical profile. Graefes Arch Clin Exp Ophthalmol 2023;261:2315–2326 18. Pérez-Sanz L, Charbel C, Poyales F, Garzón N. Influence of isofocal intraocular lenses on objective refraction based on autorefraction and aberrometry. Graefes Arch Clin Exp Ophthalmol 2023;261:2863–2872 19. Beltraminelli T, Rizzato A, Toniolo K, Galli A, Menghini M. Comparison of visual performances of enhanced monofocal versus standard monofocal IOLs in a mini-monovision approach. BMC Ophthalmol 2023;23:170 20. Choi WK, Han HJ, Son HS, Khoramnia R, Auffarth GU, Choi CY. Clinical outcomes of bilateral implantation of new generation monofocal IOL enhanced for intermediate distance and conventional monofocal IOL in a Korean population. BMC Ophthalmol 2023;23:157 21. Garzón N, Poyales F, Albarrán-Diego C, Rico-Del-Viejo L, Pérez-Sanz L, García-Montero M. Visual and optical quality of enhanced intermediate monofocal versus standard monofocal intraocular lens. Graefes Arch Clin Exp Ophthalmol 2022;260:3617–3625 22. Steinmüller LN, Greve D, Rua Amaro D, Bertelmann E, von Sonnleithner C. Analysis of higher-order aberrations in relation to the clinical outcome of an enhanced monofocal IOL. Eur J Ophthalmol 2023;33:2096–2105 23. Bova A, Vita S. Clinical and aberrometric evaluation of a new monofocal IOL with intermediate vision improvement. J Ophthalmol 2022;2022:4119698 24. Corbelli E, Iuliano L, Bandello F, Fasce F. Comparative analysis of visual outcome with 3 intraocular lenses: monofocal, enhanced monofocal, and extended depth of focus. J Cataract Refract Surg 2022;48:67–74 25. Lopes D, Loureiro T, Carreira R, Rodrigues Barros S, Cardoso JN, Campos P, Machado I, Campos N. Comparative evaluation of visual outcomes after bilateral implantation of an advanced or conventional monofocal intraocular lens. Eur J Ophthalmol 2022;32:229–234 26. Huh J, Eom Y, Yang SK, Choi Y, Kim HM, Song JS. A comparison of clinical outcomes and optical performance between monofocal and new monofocal with enhanced intermediate function intraocular lenses: a case-control study. BMC Ophthalmol 2021;21:365 27. Ucar F, Cetinkaya S. The evaluation of a new IOL with extended depth of focus to increase visual acuity for intermediate distance. SN Compr Clin Med 2021;3:2285–2291 28. Kang KH, Song MY, Kim KY, Hwang KY, Kwon YA, Koh K. Visual performance and optical quality after implantation of a new generation monofocal intraocular lens. Korean J Ophthalmol 2021;35:112–119 29. Auffarth GU, Gerl M, Tsai L, Janakiraman DP, Jackson B, Alarcon A, Dick HB; Quantum Study Group. Clinical evaluation of a new monofocal IOL with enhanced intermediate function in patients with cataract. J Cataract Refract Surg 2021;47:184–191 30. Cinar E, Bolu H, Erbakan G, Yuce B, Aslan F, Fece M, Emre S. Vision outcomes with a new monofocal IOL. Int Ophthalmol 2021;41:491–498 31. Unsal U, Sabur H. Comparison of new monofocal innovative and standard monofocal intraocular lens after phacoemulsification. Int Ophthalmol 2021;41:273–282 32. Yangzes S, Kamble N, Grewal S, Grewal SPS. Comparison of an aspheric monofocal intraocular lens with the new generation monofocal lens using defocus curve. Indian J Ophthalmol 2020;68:3025–3029 33. de Luis Eguileor B, Martínez-Indart L, Martínez Alday N, Sacristán Egüén C, Cuadros Sánchez C. Differences in intermediate vision: monofocal intraocular lenses vs. monofocal extended depth of focus intraocular lenses. Arch Soc Esp Oftalmol (Engl Ed) 2020;95:523–527 34. Mencucci R, Cennamo M, Venturi D, Vignapiano R, Favuzza E. Visual outcome, optical quality, and patient satisfaction with a new monofocal IOL, enhanced for intermediate vision: preliminary results. J Cataract Refract Surg 2020;46:378–387
Comments (0)