Clinical outcomes in a U.S. registration study of a new EDOF intraocular lens with a nondiffractive design

McCabe, Cathleen M.; Berdahl, John P.; Reiser, Harvey; Newsom, T. Hunter; Cibik, Lisa; Koch, Douglas D.; Lemp-Hull, Jessie; Jasti, Srichand

doi:10.1097/j.jcrs.0000000000000978

Cited by 21 publications

(40 citation statements)

References 16 publications

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“…Far vision (binocular UDVA) was 20/20 or better in 77% of patients and at intermediate distance, binocular UIVA was 20/25 or better in 58% of patients. Binocular UDVA and monocular CDVA reported in our study (−0.02 ± 0.07 and −0.04 ± 0.07 logMAR, respectively) are consistent with the results previously reported with the isofocal EDOF lens 17 and slightly better than those obtained with other non-diffractive EDOF IOLs (AcrySof IQ Vivity 13 , 25 , 27 and Tecnis Eyhance 23 , 24 ) and diffractive EDOF IOLs [AT LARA 829MP (Carl Zeiss Meditec) and Tecnis Symfony]. 28 …”

Section: Discussionsupporting

confidence: 93%

“… 29 AcrySof IQ Vivity with mini-monovision approach provided better binocular UIVA at 66cm and UNVA at 40 cm (0.00 to 0.06 and 0.12 to 0.23) 13 , 15 , 16 than the isofocal EDOF lens in our study. In another AcrySof IQ Vivity study without mini-monovision 27 even the monocular UNVA was as high as 0.15±0.16 logMAR, but interestingly, all patients still needed an addition of at least +1.0 D for near. The better uncorrected intermediate and near visual acuities with AcrySof IQ Vivity IOL compared to other non-diffractive EDOF IOLs, including the isofocal EDOF lens, are likely due to its slightly greater depth of focus, as mentioned before.…”

Section: Discussionmentioning

confidence: 94%

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Clinical Outcomes of a New Non-Diffractive Extended Depth-of-Focus Intraocular Lens Targeted for Mini-Monovision

Tomagova¹,

Elahi²,

Vandekerckhove³

2023

OPTH

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Purpose To assess visual acuity, binocular defocus curve, spectacle independence, and photic phenomena after bilateral same-day cataract surgery with implantation of an extended depth-of-focus intraocular lens (IOL) with mini-monovision. Methods Single-center retrospective study including 124 eyes from 62 patients who underwent bilateral implantation of an isofocal EDOF lens [Isopure® (BVI)] with mini-monovision (−0.50 D). Refraction, visual acuity at different distances, binocular defocus curves, spectacle independence, and subjective ratings of picture-referenced photic phenomena were assessed one to two months postoperatively. Results The mean postoperative refractive spherical equivalent was −0.15±0.41D in the dominant eyes and −0.46±0.35D in the mini-monovision eyes (p<0.01). Overall, 98.4% and 87.7% of the eyes were within ±1.00D and ±0.50D of the target refraction, respectively. Postoperative monocular corrected distance visual acuity was −0.04±0.07 logMAR. Binocular uncorrected visual acuity was −0.02±0.07, 0.13±0.11and 0.40±0.20 logMAR for far, intermediate and near, respectively. At the visual acuity threshold of 0.20 logMAR (or better) the defocus curve ranged from −1.6D to +0.9D. Reported spectacle-independence was 96% for far distance, 95% for intermediate, and 34% for near. Five percent of patients reported halos, 16% starburst, and 16% glare. Only 7% of all patients considered them bothersome. Conclusion In patients undergoing same-day bilateral cataract surgery, an isofocal EDOF lens provided an extended range of functional vision, up to 63 cm, resulting in useful uncorrected near vision, good uncorrected intermediate vision, and excellent uncorrected distance vision. Subjective patient satisfaction in terms of spectacle independence and photic phenomena was high.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 94%

Clinical Outcomes of a New Non-Diffractive Extended Depth-of-Focus Intraocular Lens Targeted for Mini-Monovision

Tomagova¹,

Elahi²,

Vandekerckhove³

2023

OPTH

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“…This indicates that the Vivity IOL may have a visual disturbance profile that is similar to a monofocal IOL, which has been observed in other studies. 4 , 15 , 16 The reported frequency of glare in this study (55 to 62%) appears to be higher than reports of Vivity and monofocal IOLs in other studies (33 to 53%). 4 , 12 , 16–18 Comparing patient reported outcomes across studies with different endpoints, patient populations, and methodologies is challenging, which may explain these differences.…”

Section: Discussioncontrasting

confidence: 74%

“…The results of our study suggest that the Vivity lens achieves this aim. Two large, multicenter 15 and multicounty 16 studies reported similar visual performance of the Vivity lens compared to a different monofocal IOL (SN60WF AcrySof IQ monofocal; Alcon Vision, LLC).…”

Section: Discussionmentioning

confidence: 96%

Comparative Study Between Non-Diffractive Extended Depth of Focus and Monofocal Intraocular Lenses

Kandavel¹,

Colvard²,

Dredge³

et al. 2023

OPTH

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Purpose To evaluate the visual acuity and quality of vision in bilaterally implanted ZCBOO/ZCTx monofocal (Johnson & Johnson Vision) intraocular lens (IOL) and bilaterally implanted DATx15 extended depth of focus (EDOF) IOL (Alcon Vision, LLC). Methods A single site, non-interventional study comparing ZCBOO/ZCTx monofocal IOL patients implanted with DATx15 IOL toric or non-toric versions in both eyes. A total of 30 patients (60 eyes) completed the study in the monofocal group, 32 (64 eyes) in the EDOF group, and all were targeted for emmetropia. Binocular uncorrected distance, intermediate (66cm), and near (40cm) visual acuities and distance corrected distance, intermediate (66cm) and near (40cm) visual acuities were assessed. Binocular distance corrected defocus curve testing was from −3.5 D to +3 D. Patient reported visual disturbances (QUVID) and IOL satisfaction (IOLSAT) questionnaires were administered. Results The DATx15 group mean uncorrected visual acuity was 0.15 ± 0.10 logMAR at 66cm and 0.36 ± 0.14 logMAR at 40cm, compared to 0.24 ± 0.15 logMAR and 0.59 ± 0.17 logMAR respectively for the ZCBOO/ZCTx group. The DATx15 group (23 respondents, 74%) also reported significantly more spectacle independence at near with the IOLSAT (p < 0.01), compared to the ZCBOO/ZCTx group (13 respondents, 43%). Glare, halos, starbursts, and blur reported on the QUVID questionnaire were similar in the two groups. Conclusion The DATx15 group had improved near and intermediate vision and increased spectacle independence compared to the ZCBOO/ZCTx group.

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“…However, there were some differences in this study when compared with those obtained in the Vivity's U.S. registration trial. 5 In patients bilaterally implanted with the Vivity IOL, the binocular CDVA (À0.01 ± 0.10 [≈20/20] vs À0.028 ± 0.084 [≈20/19]) and DCIVA (À0.02 ± 0.13 [≈20/19] vs 0.054 ± 0.093 [≈20/23]) were similar. 8 However, the DCNVA was 2 lines of vision better in this study (0.03 ± 0.12 [≈20/21]) than that in the U.S. registration trial (0.253 ± 0.118 [≈20/36]).…”

Section: Discussionmentioning

confidence: 99%

Vision and patient-reported outcomes with nondiffractive EDOF or neutral aspheric monofocal intraocular lenses

Pantanelli

O'Rourke

Bolognia

et al. 2022

J Cataract Refract Surg

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Clinical outcomes in a U.S. registration study of a new EDOF intraocular lens with a nondiffractive design

Abstract: This prospective, randomized study on the nondiffractive intraocular lens (IOL) DFT015 demonstrated superior intermediate and near vision, noninferior distance vision, and comparable visual disturbances to that of a monofocal IOL.

Cited by 21 publications

References 16 publications

Clinical Outcomes of a New Non-Diffractive Extended Depth-of-Focus Intraocular Lens Targeted for Mini-Monovision

Clinical Outcomes of a New Non-Diffractive Extended Depth-of-Focus Intraocular Lens Targeted for Mini-Monovision

Comparative Study Between Non-Diffractive Extended Depth of Focus and Monofocal Intraocular Lenses

Vision and patient-reported outcomes with nondiffractive EDOF or neutral aspheric monofocal intraocular lenses

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