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Open label study of WP-2011 multifocal intraocular lens in patients with aphakic eye patients after cataract surgery

WP-2011

127

117 eyes (66 subjects) were implanted with investigational device, demographics of 117 eyes are as follow: Mean age: 63.1(SD: 9.05) years Genders of subjects (male/female): 40.9% / 59.1% implanted lenses: WP-2011N (non-toric intraocular lens): 60 eyes (37 subjects), WP-2011T (toric intraocular lens) : 57 eyes (33 subjects)

First patient first visit: June 8, 2021 Last patient last visit: June 13, 2023 Informed consents were obtained from 127 eyes, 9 eyes failed complete the screening process. And among enrolled 118 eyes, 1 eye withdrew consent before the preoperative examination, A total of 117 eyes (66 subjects) were implanted with investigational device.

In this study, serious adverse events occured in 5 subjects, but these events were assessed not related to the investigational device by the principal investigator. <Ocular Adverse Events: 42 of 117 eyes (35.9%) [WP-2011N: 26 events of 60 eyes (43.3%), WP-2011T: 16 events of 57 eyes (28.1%)]> Major Ocular adverse events Posterior capsule opacification : 22 of 117 eyes (18.8%) Dry Eye Syndrome : 9 of 117 eyes (7.7%) Allergic conjunctivitis : 4 of 117 eyes (3.4%) Ocular hypertension : 2 of 117 eyes (1.7%) Conjunctivitis: 2 of 117 eyes (1.7%) Intraocular pressure increased: 2 of 117 eyes (1.7%) There were no ocular severe adverse events. <Non-ocular Adverse Events: 24 of 66 subjects (36.4%) [WP-2011N: 13 of 37 subjects (35.1%), WP-2011T: 11 of 33 subjects (33.3%)]> These nonocular adverse events were assessed not related to the investigational device by the principal investigator. < Device Deficiencies 5 of 117eyes (4.3%) [WP-2011N : 3 of 60eyes (5.0%), WP-2011T: 2 of 57eyes (3.5%)] > These defects were related to the injector and did not occur after measures were taken regarding the handling of the injector.

<Primary endpoint> (WP-2011N and WP-2011T) 1) Percentage of eyes with distance corrected visual acuity (5 m) of 0.5 or better at 6 months after surgery 2) Percentage of eyes with distance corrected intermediate visual acuity (80 cm) of 0.5 or better at 6 months after surgery 3) Percentage of eyes with distance corrected near visual acuity (40 cm) of 0.5 or better at 6 months after surgery (WP-2011T only) 4) Prediction error of astigmatism at 6 months postoperatively (Percentage of eyes 0.5D or less/1.0D or less). <Results> WP-2011N implanted eyes At 6 months after surgery, the percentage of eyes with distance corrected visual acuity (5 m) of 0.5 or better was 100% (60/60 eyes), the percentage of eyes with distance corrected intermediate visual acuity (80 cm) of 0.5 or better was 98.3% (59/60 eyes), and the percentage of eyes with distance corrected near visual acuity (40 cm) of 0.5 or better was 95.0% (57/60 eyes). WP-2011T implanted eyes At 6months after surgery, the percentage of eyes with distance corrected visual acuity (5 m) of 0.5 or better was 100% (57/57 eyes), the percentage of eyes with distance corrected intermediate visual acuity (80 cm) of 0.5 or better was 100% (57/57 eyes), and the percentage of eyes with distance corrected near visual acuity (40 cm) of 0.5 or better was 96.5% (55/57 eyes). Furthermore, 96.5% (55/57 eyes) of eyes were within 1.0D of the target refractive cylinder at 6 months after surgery. In most eye, the error from the target refractive cylinder was within 1.0D, demonstrating the effectiveness of astigmatism correction with implantation of the investigational device. These results showed that all observation met the evaluation criteria, demonstrating the effectiveness of WP-2011N and WP-2011T.

The investigational device was shown to be effective and safe for correcting visual acuity at far, intermediate and near distances and correcting astigmatism in aphakia after cataract operation.

May. 16, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2032210035

Ichikawa Kazuo

Chukyo Eye Clinic

12-22, Sanbonmatsu-cho Atuta-ku, Nagoya-shi, Aichi-ken

chiken1@chukyogroup.jp

Kami-ie Hideyuki

Wakamoto Pharmaceutical Co., Ltd.

2-2, Nihonbashi Honcho 2-chome, Chuo-ku Tokyo

+81-3-3279-0370

hideyuki.kamiie@wakamoto-pharm.co.jp

Complete

April. 12, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients who scheduled to remove the crystalline lens by phacoemulsification and aspiration

Patients with indication for secondary lens implantation.
Patients with uncontrolled glaucoma.
Pregnant women, lactating women or women who desire to be pregnant.
Patients who are judged inappropriate to participate in the study by principal investigator or sub-investigator.

Both

Cataract

Implantation of intraocular after cataract surgery

Visual acuity after lens implantation.
Incidence of adverse events and defects.

+81-42-648-5551

Mar. 25, 2021

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