Astigmatism, Cataract
Conditions
Brief summary
Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery.
Detailed description
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
Interventions
DEVICEtoric intraocular lens
Sponsors
Nidek Co. LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | postoperative 6 months | Visual acuity with pre-determined spherical correction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | postoperative 6 months | UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent |
| IOL rotation | postoperative 6 months | angle of rotation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | one year | Severity and causal relationship |
Outcome results
None listed