One-year multicenter evaluation of a new hydrophobic acrylic intraocular lens with hydroxyethyl methacrylate in an automated preloaded delivery system

Oshika, Tetsuro; Sasaki, Noriyuki; System, Delivery

doi:10.1097/j.jcrs.0000000000000746

Cited by 14 publications

(24 citation statements)

References 25 publications

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“… 4 Similarly, in a 1-year study in 384 patients in Japan, the Clareon IOL demonstrated good visual acuity and low postoperative refractive error. At 12 months, 95% of eyes achieved BCDVA of 20/25 (~0.2 logMAR) or better, and refractive error in 90% of eyes was within 1.0 D. 6 A 4- to 6-week follow-up study that evaluated the Clareon AutonoMe system in 144 eyes in Germany also reported good visual acuity and low postoperative refractive error; in patients without ocular comorbidities, BCDVA improved from 0.27 to 0.03 logMAR. 15…”

Section: Discussionmentioning

confidence: 95%

“…eyes was within 1.0 D. 6 A 4-to 6-week follow-up study that evaluated the Clareon AutonoMe system in 144 eyes in Germany also reported good visual acuity and low postoperative refractive error; in patients without ocular comorbidities, BCDVA improved from 0.27 to 0.03 logMAR. 15 The material and design of the Clareon IOL were aimed to reduce the risk of PCO and to achieve low levels of surface haze and glistenings.…”

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confidence: 87%

“…The Clareon IOL uses flexible acrylic material (PEA/HEMA copolymer) with a 1.5% water content (Table 1) 4 and an advanced manufacturing process that improves lens clarity by minimizing glistenings, surface nanoglistenings, and surface haze, as demonstrated by in vitro and in vivo clinical studies. [4][5][6] The precision edge of the Clareon IOL was designed to minimize edge glare and reduce posterior capsular opacification (PCO). Using optical simulation with a schematic model eye, Clareon IOL showed lower edge glare compared with other lenses.…”

Section: Introductionmentioning

confidence: 99%

“…However, PCO rates can vary among studies; Japanese patients reported that 0.9% of eyes (2/230) required Nd:YAG capsulotomy during 12 months of follow-up. 6 In another study, Nd:YAG capsulotomy was performed in 1.5% of eyes during the 12-month follow-up. 16 The surface roughness of the IOL, measured using atomic force microscopy, may affect the incidence of PCO.…”

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confidence: 99%

“…Our results were consistent with previous in vitro and in vivo clinical studies that reported grade 0 glistenings at 12 months in patients implanted with Clareon IOLs. [4][5][6]16 The edge architecture of the Clareon IOL contributed to the low PCO formation and reduced the edge-reflected and edge-transmitted glare. A study using ray tracing demonstrated that the Clareon IOL produced less edge glare compared with other commercially available IOLs (Tecnis ZCB00, enVista MX60, Eternity W-60, and Vivinex XY1 [Hoya Surgical Optics, Inc.]).…”

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confidence: 99%

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Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population

Titiyal¹,

Basak²,

Shetty³

et al. 2022

OPTH

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Purpose To assess real-world clinical outcomes and safety of the Clareon ® intraocular lens (IOL) and AutonoMe ® automated preloaded delivery system in an Indian population. Patients and methods This was a prospective, single-arm, multicenter, 12-month clinical study in patients aged ≥20 years with unilateral or bilateral cataracts. Surgery was performed by phacoemulsification followed by implantation of the Clareon monofocal IOL (CNA0T0). Monocular best-corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity (UCDVA) were assessed at 1 week and 1, 6, and 12 months after implantation. Posterior capsular opacification (PCO), surface haze, and glistenings were evaluated at all visits. Surgeons’ satisfaction with automated injector system was also evaluated using a questionnaire. Safety was assessed by monitoring adverse events (AEs). Results A total of 151 eyes received the CNA0T0 IOL. Mean ± SD monocular BCDVA improved from 0.53±0.44 logMAR preoperatively to 0.00±0.08 logMAR at week 1 and −0.03±0.08 logMAR at 12 months after implantation. At 12 months, 137/137 (100%) of eyes achieved BCDVA of 0.3 logMAR or better. Mean ± SD monocular UCDVA was 0.78±0.40 logMAR preoperatively, 0.11±0.15 logMAR at week 1, and 0.08±0.13 logMAR at 12 months after implantation. At 12 months, 132/137 (96%) eyes achieved UCDVA of 0.3 logMAR or better. Serious intraoperative AEs were posterior capsule rupture (n=1) and ciliary zonular dehiscence (n=1). Surgeons reported that the automated preloaded device was more intuitive compared with other push- or screw-style preloaded injector systems. None of the eyes in this study presented surface haze; all were graded as 0 glistenings at all visits. No clinically significant PCO or neodymium-doped yttrium aluminum garnet (Nd:YAG) capsulotomies were reported. Conclusion The hydrophobic IOL preloaded in an automated injector system provided good visual and refractive outcomes, as well as no surface haze and grade 0 glistenings. None of the patients required Nd:YAG capsulotomy.

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Section: Discussionmentioning

confidence: 95%

mentioning

confidence: 87%