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A Multicenter, Single-Arm, Open-Label Clinical Trial to Evaluate the Efficacy and Safety of the Toric Intraocular Lens N3T in Cataract Patients with Corneal Astigmatism

A Multicenter, Single-Arm, Open-Label Clinical Trial to Evaluate the Efficacy and Safety of the Toric Intraocular Lens N3T in Cataract Patients with Corneal Astigmatism

Ichimura Tadakazu

NIDEK CO., LTD.

34-14 Maehama, Hiroishi-cho, Gamagori-shi, Aichi

clinical-trials@nidek.co.jp

Ichimura Tadakazu

NIDEK CO., LTD.

34-14 Maehama, Hiroishi-cho, Gamagori-shi, Aichi

+81-533-67-8904

clinical-trials@nidek.co.jp

Recruiting

Mar. 27, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Patients with an age of >=40 years when signed and dated informed consent.
(2) Patients with age-related cataract in one or both eyes.
(3) Patients with a pupil diameter of >=5 mm in the study eye under mydriasis.
(4) Patients whose calculated lens power for the study eye is within the range of the investigational device's equivalent spherical power and cylindrical refractive power.
(5) Patients whose predicted postoperative astigmatism in the study eye is <0.5 D.
(6) Patients whose postoperative uncorrected visual acuity with spherical addition in the study eye is expected to be >=0.8.
(7) Patients who are willing to undergo the required postoperative examinations and able to complete all visits throughout the study period.
(8) Patients who understand the informed consent document and are able to provide written informed consent.

If both eyes meet the inclusion criteria, both eyes may be included in the study. However, for patient safety, surgery on the fellow eye should be performed at least 1-2 weeks after the postoperative examination of the first operated eye.

(1) Patients with the following diseases in the study eye:
-Irregular corneal astigmatism
-Corneal abnormalities such as stromal, epithelial, or endothelial dystrophies
-Corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
-Corneal disorders (e.g., corneal opacity, pterygium, superficial punctate keratitis)
-Degenerative retinal disorders in which retinal findings indicate a postoperative visual prognosis of <0.6 decimal visual acuity (e.g., macular degeneration, retinal degeneration, other retinal disorders)
-Diabetic retinopathy
-Abnormalities associated with an increased risk of zonular rupture (e.g., zonular weakness, capsular abnormalities, pseudoexfoliation syndrome)
-Markedly shallow anterior chamber
-Microphthalmos
-Long axial length (>=28 mm)
-Active inflammation in the anterior or posterior segment
-Uncontrolled ocular hypertension or glaucoma
-Optic nerve atrophy
-Congenital ocular abnormalities
-Poor mydriasis
-Severe dry eye or other ocular surface abnormalities
-Systemic diseases affecting the eye (e.g., atopic disease)
(2) Patients who require or have previously undergone corneal transplantation in the study eye.
(3) Patients with a history of corneal refractive surgery in the study eye.
(4) Patients for whom a secondary surgical procedure in the study eye is reasonably expected during the study period (except for YAG laser posterior capsulotomy, which is permitted).
(5) Patients who are participating in another clinical trial of a drug or medical device at the time of informed consent, or who are expected to participate in another clinical trial during this study.
(6) Patients with cognitive impairment or psychiatric disorders that may interfere with accurate examinations or measurements.
(7) Pregnant or lactating women; women who are pregnant or who may become pregnant (e.g., positive pregnancy test); or women who intend to become pregnant or who cannot use appropriate contraception during the study period.
(8) Any other patients deemed unsuitable for participation by the principal investigator or sub-investigator.

Both

Cataract with corneal astigmatism

Cataract surgery with posterior chamber intraocular lens (N3T100, N3T150, N3T225, N3T300, N3T375, and N3T450) preloaded in injector.

(1) Proportion of subjects achieving an uncorrected visual acuity with spherical addition of >=0.8 at 4-6 months postoperatively for N3T150, N3T225, N3T300, N3T375, and N3T450.
(2) Refractive astigmatism (manifest refractive cylinder) at 4-6 months postoperatively for N3T100.

Efficacy Endpoints
(1) Uncorrected Visual Acuity (UCVA)
(2) Uncorrected Visual Acuity with Spherical Addition (non-primary endpoint)
(3) Best Spherical Distance-Corrected Visual Acuity
(4) Best-Corrected Visual Acuity (BCVA)
(5) Refractive astigmatism (non-primary endpoint)
(6) Manifest Refraction
(7) Intraocular Lens Rotation

Safety Endpoint
Number and incidence rate of adverse events for which a causal relationship with the investigational device cannot be ruled out.

+81-52-251-6571

Feb. 24, 2026

+81-92-431-1680

Feb. 24, 2026

Feb. 24, 2026

No

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