Clinical Evaluation of Toric Intraocular Lens

Study Overview
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Brief Summary
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Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery.

Detailed Description
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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

Official Title
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Safety and Effectiveness Evaluation of Toric Intraocular Lens

Conditions
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Cataract, Astigmatism

Intervention / Treatment
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* Device: toric intraocular lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: toric intraocular lens<br>toric intraocular lens is implanted to all subjects | Device: toric intraocular lens<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Visual acuity with pre-determined spherical correction | postoperative 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent | postoperative 6 months | 
| IOL rotation | angle of rotation | postoperative 6 months |