Safety and Effectiveness Evaluation of Toric Intraocular Lens
| Registry | NCT03242486 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 64 (Actual) |
| Sponsor | Nidek Co. LTD. (Industry) |
| Conditions | Cataract, Astigmatism |
| Interventions | toric intraocular lens (Device) |
| Dates | start 2014-12-01, primary completion 2017-05-01, completion 2017-12-01, first posted 2017-08-08, last updated 2018-02-20 |
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Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery.
Effectiveness
* primary endpoint is visual acuity with pre-determined spherical correction.
* secondary endpoint is UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent, IOL rotation
Safety
* number and percentage of adverse event
| Arm | Type | Interventions | Description |
|---|---|---|---|
| toric intraocular lens | Experimental | Device: toric intraocular lens | toric intraocular lens is implanted to all subjects |
Sex: All, ages: 40 Years to any
Inclusion Criteria: * Patients with age of 40 years or older * Patients with age-related cataract in one eye or both eyes. * Patients willing to participate in the required postoperative study. * Patient who can understand and sign the consent document. * An eye whose pupil diameter after mydriasis is 5 mm or greater. * An eye whose preoperative corneal cylindrical power is 1.0D or more. * An eye whose postoperative astigmatism is predicted to be less than 0.5 D. * An eye whose postoperative visual acuity with spherical addition is 0.8 D or more. Exclusion Criteria: * Disorder of corneal endothelium * Uncontrolled glaucoma * Active Uveitis * Diabetic retinopathy * Retinal detachment * Congenital ocular anomalies * Choroidal hemorrhage * Shallow anterior chamber * Microphthalmus * Corneal dystrophy * Optic atrophy * Ocular hypertension * Amblyopia * Previous history of corneal transplantation * Active Iritis * Corneal disorder * Macular degeneration * Retinal degeneration * Clinically significant change in macula and/or retinal pigment epithelium * Corneal irregular astigmatism * Atopic disease * Brittleness of Zinn's zonule, fractured zonule and lens luxation (including subluxation) * Pseudo-exfoliation syndrome * Iris neovascularization * Long axis length eye (axis length : 28mm or more) * Severe dry eye, abnormality of the lens surface * Concurrent participation in another drug and device clinical investigation * Patient with mental deficiency or psychiatric disorder and/or who is not capable of expressing the consent of participating in the trial * Patient who is judged inappropriate by investigators or sub-investigators