Rotational stability and clinical outcomes of a new one piece toric intraocular lens with anchor-wing haptics

Iichiro Sugita; Tomoichiro Ogawa; Kazuo Ichikawa; Takahide Okita; Kazuno Negishi; Tadashi Nakano; Hiroshi Tsuneoka

doi:10.1186/s12886-021-02240-7

Rotational stability and clinical outcomes of a new one piece toric intraocular lens with anchor-wing haptics

BMC Ophthalmol. 2022 Jan 15;22(1):26. doi: 10.1186/s12886-021-02240-7.

Authors

Iichiro Sugita¹, Tomoichiro Ogawa^{2

3}, Kazuo Ichikawa⁴, Takahide Okita⁵, Kazuno Negishi⁶, Tadashi Nakano², Hiroshi Tsuneoka²

Affiliations

¹ Sugita Eye Hospital, 5-1-30, Sakae, Naka-ku, Nagoya-shi, Aichi, 460-0008, Japan. iichiro@sugita.or.jp.
² Department of Ophthalmology, the Jikei University School of Medicine, 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.
³ Miyamaedaira Ogawa Eye Clinic, 19-14, Nanpeidai, Miyamae-ku, Kawasaki-shi, Kanagawa, 216-0024, Japan.
⁴ Chukyo Eye Clinic, 12-22, Sanbonmatsu-cho, Atsuta-ku, Nagoya-shi, Aichi, 456-0032, Japan.
⁵ Sugita Eye Hospital, 5-1-30, Sakae, Naka-ku, Nagoya-shi, Aichi, 460-0008, Japan.
⁶ Department of Ophthalmology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.

Abstract

Background: To evaluate the safety and efficacy of a new toric intraocular lens (IOL) with anchor-wing haptics.

Methods: The new toric IOL with anchor-wing haptics (NS60YT, NIDEK Co., Ltd.) was implanted in eligible patients with age-related cataracts with preoperative corneal astigmatism of 1.0 D or greater at a university hospital and two private hospitals in Japan. The following IOL cylinder powers were evaluated: 1.50 D (NS60YT3), 2.25 D (NS60YT4), 3.00 D (NS60YT5) and 4.50 D (NS60YT7). All patients were assessed out to 12 months postoperatively. The primary endpoint was visual acuity (VA) with spherical addition at 6 months postoperatively, and the primary analysis calculated the proportion of eyes with VA with spherical addition of 0.1 logMAR or better. The magnitude of rotation was compared to the intended axis of IOL implantation at each postoperative examination. Adverse events were evaluated for the safety analysis.

Results: This study enrolled 64 eyes of 53 patients. At 6 months postoperatively, for all IOL powers, VA with spherical addition of 0.1 logMAR or better was achieved in 90% [95% confidence interval (CI): 80-96] of eyes. The mean IOL rotation was 5.3 ± 4.3° at 12 months postoperatively. The mean magnitude of rotation ranged from 1.9° to 2.5° between each postoperative examination from 1 day to 12 months. There were no vision-threatening intraoperative or postoperative complications for the duration of the study.

Conclusions: The NS60YT IOL remained stable after implantation and was efficacious for treating 1.00 D or greater astigmatism in patients with senile cataracts.

Trial registration: This study was registered at ClinicalTrials.gov ( NCT03242486 ) on August 8, 2017 - Retrospectively registered.

Keywords: Anchor-wing haptics; Cataract; Cataract surgery; Corneal astigmatism; Intraocular lens; Rotational stability; Toric intraocular lens.

MeSH terms

Astigmatism* / surgery
Cataract* / complications
Haptic Technology
Humans
Lens Implantation, Intraocular
Lenses, Intraocular*
Phacoemulsification*
Refraction, Ocular
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT03242486