Cataract with corneal astigmatism
Conditions
Interventions
Cataract surgery with posterior chamber intraocular lens (N3T100, N3T150, N3T225, N3T300, N3T375, and N3T450) preloaded in injector.
Sponsors
Ichimura Tadakazu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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 =0.8. (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.
Exclusion criteria
Exclusion criteria: (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 =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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactTadakazu Ichimura
NIDEK CO., LTD.
Outcome results
None listed