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SP2Y-GMF CLINICAL STUDY

Clinical Study to Evaluate the Safety and Performance of the Intraocular Lens (Investigational Device Development Code: SP2Y-GMF) After Implantation.

64

The percentage of male was 31.3 % (20 of 64 subjects) and that of female was 68.8 % (44 of 64 subjects). The mean age of subjects was 64.1 years, with a range of 39 to 76 years.

Of the 65 enrolled subjects (130 eyes), 1 subject (2 eyes) dropped out before surgery due to withdrawal of consent. Cataract operation was performed in 128 eyes of 64 subjects. No subjects underwent unilateral IOL implantation or discontinued during surgery. One subject (2 eyes) discontinued the clinical investigation postoperatively due to an adverse event not related to the investigational device. A total of 126 eyes of 63 subjects completed the clinical investigation.

The incidence of adverse events categorized into "eye disorders" and considered to be related to the investigational device was 4.7 % (6 of 128 eyes). These events consisted of "halo vision," "photopsia," "glare," and "loss of visual contrast sensitivity". Of the above "eye disorders," serious adverse events included 2 events of "loss of visual contrast sensitivity" and 1 event of "halo vision". The incidence of adverse events categorized into "other than eye disorders" and considered to be related to the investigational device was 1.6 % (1 of 64 subjects). These events consisted of "oral herpes" and "sleep disorder", which could have been caused by the stress from "halo vision".

Primary endpoint 1) The percentage of eyes with UNVA >= 0.5 at Postop Month 4-6 was 96.0 %. The investigational device was shown to be non-inferior to the approved similar diffractive multifocal IOLs in terms of performance. Primary endpoint 2) The percentage of eyes with subjective astigmatism of <= 0.50 at Postop Month 4-6 in all eyes implanted with XY1-GT2 was 92.9 %. The performance on astigmatism reduction of XY1-GT2 was shown to be superior to non-toric IOLs.

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

Aug. 19, 2023

No

NA

https://jrct.mhlw.go.jp/latest-detail/jRCT2072210002

Eguchi Shuichiro

Eguchi Eye Hospital

7-13 Suehiro-cho, Hakodate-shi, Hokkaido 040-0053 Japan

eguchi@muh.biglobe.ne.jp

Motono Soichiro

HOYA CORPORATION Medical Division

4-10-2 Nakano, Nakano-ku, Tokyo 164-8545 Japan

+81-3-5913-2347

mejp-chiken@hoya.com

Complete

Mar. 23, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Patients with bilateral cataract, aged 22 or more years at the time of consent
2) Patients who desire to receive bilateral cataract surgery and implantation
3) Patients with planned 2nd eye surgery within the period of 7-30 days after the 1st eye surgery
4) Other patients who meet the inclusion crirteria stipulated in the clinical trial protocol

1) Patients with history of corneal transplant
2) Patients with history of refractive surgery
3) Patients with history of intraocular surgery
4) Patients with glaucoma
5) Patients with previous or acute retinal detachment
6) Patients with retinal degenerative disorders
7) Patients with a plan to have an intraocular surgery other than implantation of the investigational devices during the study period
8) Other patients who meet the exclusion crirteria stipulated in the clinical trial protocol

Both

Cataract

Cataract sugery with posterior chamber lens preloaded in an injector.
Insert the injector nozzle through the incision and release the intraocular lens into the lens capsule. At that time, do not rotate the inserter itself. Pull the injector back from the incision and use a hook or other device to adjust the intraocular lens to the proper position.

D002386

D002387

Performance
1) Percentage of eyes with Uncorrected Near Visual Acuity 0.5 or more decimal at Month 4-6
2) Percentage of eyes with subjective astigmatism 0.50D or less at Month 4-6 in all eyes implanted with minimum cylinder power lens

+81-92-431-1680

Feb. 16, 2021

none