Visual and optical quality of enhanced intermediate monofocal versus standard monofocal intraocular lens

Abstract

Purpose Intraocular lens designs are constantly evolving, trying to obtain more spectacle independence after cataract surgery. This advantage can be linked to some disadvantages, such as optical quality decrease. For that reason, it is important to assess, not only the amount of vision provided but also the quality of vision once they are implanted. The purpose of the present work was to compare the visual performance between two monofocal intraocular models: a standard model and a monofocal with enhanced intermediate vision lens. Methods Prospective, randomized, comparative study. Sixty adult subjects scheduled to undergo bilateral cataract surgery and IOL implantation were randomized to receive one of the two IOLs in both eyes at Miranza IOA, Madrid, Spain (group A: monofocal with enhanced intermediate vision lens and group B: standard monofocal lens). Monocular outcomes (right eyes) determined 1 and 3 months postoperatively were photopic corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), perceived halo, corrected intermediate-distance contrast sensitivity, and higher-order aberrations. The impact of the new IOL in the postoperative management with autorefraction devices was also evaluated. Results No differences were found in CDVA between the two groups. Significant differences were detected between the two lenses evaluated in both total HOA (p = 0.028) and internal HOA (p = 0.037). Contrast sensitivity and halometry results obtained at 1 month were similar across the two IOL groups. Conclusion In patients undergoing cataract surgery, monofocal with enhanced intermediate vision IOL offered similar distance performance and contrast sensitivity along with perceived HOA and halos compared with the standard monofocal IOLs tested.

Positioning of enhanced monofocal intraocular lenses between conventional monofocal and extended depth of focus lenses: a scoping review

“…Regarding the laboratory evidence, the elevation changes for refractive EDoF lenses were not achieved for Table 5 Criteria accomplished by the enhanced monofocals according to the ANSI standard definition of EDOF lenses and additional points RCT Randomized clinical trial, CS Case series ANSI-1: Statistical significance versus control for mean monocular visual acuity, with distance correction, at an intermediate distance of 66 cm ANSI-2: An increase in depth of field is achieved in the monocular defocus curve with distance correction equal to or greater than 0.5 D for a visual acuity level of 0.2 logMAR ANSI-3: The median monocular visual acuity, with distance correction, at an intermediate distance of 66 cm, is at least 0.2 logMAR ANSI-4: Monocular acuity at distance, with correction at this distance, is statistically non-inferior to control using a non-inferiority margin of 0.1 logMAR Add-1: Statistical significance versus control for mean binocular visual acuity, with distance correction, at an intermediate distance of 66 cm Add-2: An increase in depth of field is achieved in the binocular defocus curve with distance correction equal to or greater than 0.5 D for a visual acuity level of 0.2 logMAR Add-3: The mean monocular visual acuity, with distance correction, at an intermediate distance of 66 cm, is at least 0.2 logMAR Add-4: Starting with CDVA, the monocular defocus range at 0.2 logMAR is ≥ 1.5 and < 2. Bova et al [44], Nanavaty et al [39], Corbelli et al [49], Lopes et al [40], Steinmüller et al [17], Auffarth et al [45], Ucar et al [37], Kang et al [41], Unsal et al [38], Cinar et al [42], Huh et al [28], Yangzes et al [36], Eguileor et al [43], Mencucci et al [3], Garzón et al [46] the Tecnis Eyhance [31,32], and the optical quality studies that included both, enhanced monofocals and EDoF lenses, showed a higher depth of focus range with poorer distance optical quality for EDoF lenses in comparison to enhanced monofocals [25,27]. These laboratory results were in agreement with clinical evidence of studies including enhanced monofocals and EDoF lenses, demonstrating a higher range of focus and better DCNVA for the latter [33][34][35]49].…”

“…Three clinical studies compared enhanced monofocals with EDoF lenses, [33][34][35] 14 compared the clinical results with a standard monofocal, [3,17,28,[36][37][38][39][40][41][42][43][44][45][46] and three case series without a comparison group were identified [16,47,48] Only one study included both monofocal and EDoF lenses in comparison to Tecnis Eyhance [49]. Supplemental file B contains all the data extracted from clinical studies.…”

“…Although four randomized clinical trials (RCT) were identified, [39,43,45,46] none accomplished all the requirements described by the ANSI for evaluating the EDOF criteria. Table 5 summarizes the criteria for classifying an intraocular lens as an EDOF according to the ANSI standard.…”

Enhanced vs conventional monofocal intraocular lens clinical results in patients with cataract: randomized clinical trial

“…Moreover, it allows greater independence from spectacles in day-to-day activities, such as window shopping and playing board games, and when using electronic devices, such as PCs, iPads, and cell phones, which are increasingly used by patients undergoing cataract surgery. 10,13 Although there are several retrospective, observational case series and case-control studies that compare the enhanced and conventional monofocal IOLs, there are only a few randomized comparative prospective studies. 1,3,4,[8][9][10][11][13][14][15][16] These do not assess patient satisfaction and the presence of positive dysphotopsias.…”

“…10,13 Although there are several retrospective, observational case series and case-control studies that compare the enhanced and conventional monofocal IOLs, there are only a few randomized comparative prospective studies. 1,3,4,[8][9][10][11][13][14][15][16] These do not assess patient satisfaction and the presence of positive dysphotopsias. Thus, the main aim of this randomized clinical trial was to assess the primary endpoints of binocular intermediate and distance visual acuity and secondary endpoints that included patient satisfaction and positive dysphotopsias.…”