A new functional classification can help achieve precise vision goals
Monofocal IOLs that are designed to slightly enhance depth of field or range of field (ROF) represent a novel approach to meeting patient expectations. These lenses were based on the concept that some patients naturally achieved a degree of spectacle independence at intermediate distances due to smaller pupil diameters, slightly myopic targeting, or inherent corneal aberrations.
However, this relatively new category of lenses has not always been well characterised. The lenses are marketed as “monofocal plus” IOLs without consistent definitions for what exactly distinguishes them from a standard monofocal on the one hand or—at the other end of the spectrum—from a presbyopia-correcting lens.
The European Society of Cataract and Refractive Surgeons (ESCRS) Functional Vision Working Group, of which I am the coordinator, published a proposed 6-category classification in which IOLs are subdivided into either partial or full ROF in the defocus curve.1
Each of these two categories is further subdivided into functional classifications based on the extent of the ROF and the improvement in intermediate-to-near visual acuity (DVA) (Table 1).
Partial–ROF Enhanced IOLs are suitable for patients seeking greater spectacle independence at intermediate distances compared to conventional monofocal lenses (partial RoF-narrowed).
These lenses do not compromise distance vision as partial–RoF extended lenses might, although achieving intermediate spectacle independence is less predictable compared to partial–ROF extended lenses (often referred to as extended depth-of-field or EDOF IOLs).
This functional classification (Table 2) can increase clinicians’ certainty regarding expected outcomes, particularly with respect to intermediate vision. We know that intermediate vision is important to our patients because it encompasses many everyday tasks performed at arm’s length, such as using computers, tablets and smartphones; cooking; driving (particularly dashboard visibility) and social interactions. Enhancing patients’ intermediate vision can positively impact their quality of life, independence and satisfaction after cataract surgery.
My colleagues and I recently conducted a systematic review and meta-
analysis of studies comparing the Tecnis Eyhance IOL with a wide range of other IOLs, including those marketed as conventional monofocal or monofocal “plus” IOLs.2 The Tecnis Eyhance IOL is well represented in the literature and was known to fit within the partial ROF–enhanced category of the ESCRS classification system. It has an aspheric surface with a continuous increase in power from the periphery to the centre of the lens.
In all, 31 studies were deemed eligible for inclusion in the analysis. To avoid classification bias, we compared the study lens (Tecnis Eyhance) with all other comparators, regardless of how those comparators have been marketed. The comparator lenses included all those compared with Tecnis Eyhance at the time the systematic search was conducted: AcrySofIQ SN60WF; Clareon CNA0T0 or CCA0T0; enVista or enVista Toric; IsoPure; RayOne Monofocal; SofPort; Tecnis ZCB00, PCB00, or AAB00; Vivinex Impress; Vivinex iSert and Zoe Primus-HD. A sub-analysis was then conducted to identify additional IOLs from this list that might meet the partial–ROF enhanced criteria.
A common challenge in meta-analyses is that not all studies evaluate the same variables and not all are conducted with the same degree of scientific rigor and/or lack of bias. Where available, we evaluated the study lens against the comparator lenses primarily with regard to monocular distance-corrected acuities, monocular distance-corrected defocus curve and monocular distance-corrected contrast sensitivity. Binocular outcomes, photic phenomena, positive dysphotopsia, spectacle independence and satisfaction were also evaluated where possible.
The study lens demonstrated the highest level of evidence supporting
its efficacy as a partial–ROF enhanced IOL under the classification guidelines. This lens improved intermediate and near monocular and binocular visual acuities by 1.0 to 1.5 lines of vision and significantly improved spectacle independence at intermediate distance. Compared with comparator IOLs in studies with the same end-points, the study lens increased the odds of achieving spectacle independence at intermediate distance without increasing the likelihood of photic phenomena. Distance contrast sensitivity (CS) and positive dysphotopsia outcomes also did not significantly differ between the study lens and comparator IOLs.
The inclusion of patients with ocular comorbidities such as early glaucoma or retinal conditions in some of the studies in the meta-analysis did not change the conclusion that Eyhance provided superior performance compared with conventional monofocals. However, few studies included these types of patients, so clinicians should be cautious about generalising these results to their patients with comorbid conditions.
A subgroup analysis demonstrated that Zoe Primus-HD, Vivinex Impress and IsoPure offered similar performance to the study lens in monocular distance-corrected intermediate and near DVA. These three lenses may also provide similar outcomes to the study lens in monocular distance-corrected defocus curves.
Of note, each of the three comparator IOLs is supported by only one non-randomised study. Additional clinical studies on these IOLs are needed to provide further evidence that they should be classified as partial–ROF enhanced lenses. Fully understanding the scientific evidence for monofocal plus IOL classification is essential. The ESCRS Functional Vision Working Group has proposed that modified monofocal IOLs could be standard of care if there is enough scientific evidence to confirm their clinical superiority over conventional monofocal IOLs and if their benefits justify any additional costs.3
As this meta-analysis reveals, monofocal IOLs marketed with a “plus” designation do not necessarily provide an enhanced depth or range of field. In a rich market with various IOLs and marketing claims, the evidence presented in this meta-analysis offers surgeons a reliable foundation for setting realistic patient expectations.
IOLs that provide a partial–ROF enhanced functional response increase the predictability of achieving intermediate spectacle independence, regardless of individual ocular characteristics or surgeon-related factors. This enhanced predictability allows surgeons to offer patients a greater likelihood of functional visual performance at intermediate distances.
The investigators' institution received an unrestricted research grant from Johnson & Johnson to perform this meta-analysis.
Joaquín Fernández Pérez, MD, PhD, MSc | E: joaquinfernandezoft@qvision.es
Fernández is CEO of Qvisión, ophthalmic medical director at Vithas Virgen del Mar Hospitals, and founding patron of the Elena Barraquer Foundation in Almería, Spain.
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