Evaluation of the Rotational Stability of the Tecnis Toric II IOL

Study Overview
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Brief Summary
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This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for up to 3-months postoperatively.

Official Title
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Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular Lens

Conditions
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Cataract, Corneal Astigmatism

Intervention / Treatment
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* Device: TECNIS® Toric II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum 22 years of age; Unilateral or Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned; Pre-existing corneal astigmatism of one diopter or greater; Predicted residual refractive cylinder based on toric IOL calculator, considering surgically induced astigmatism (SIA) and posterior corneal astigmatism (PCA) must be ≤0.50 D; Potential for postoperative BCDVA of 20/30 Snellen or better; Clear intraocular media other than cataract in each eye; Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits; Signed informed consent form (ICF) and health insurance portability and accountability act (HIPAA) authorization; Ability to understand and respond to a questionnaire in English. Exclusion Criteria: Irregular corneal astigmatism; Any corneal pathology/abnormality other than regular corneal astigmatism or corneal instability due to contact lens wear; Previous corneal or intraocular surgery; Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.); Any pupil abnormalities (non-reactive, fixed, or abnormally shaped pupils); Dilated pupil size of < 6.0 mm; Recurrent severe anterior or posterior segment inflammation or uveitis; Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects; Known ocular or systemic disease that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, [macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.]; Use of systemic or ocular medications (e.g., Flomax) that may affect vision including prior, current, or anticipated use during the course of the study that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery); Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes; Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study. Planned monovision correction (eye designated for near correction)

Ages Eligible for Study
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Minimum Age: 22 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: TECNIS® Toric II<br>Subjects will be implanted in one or both eyes with the study lens | Device: TECNIS® Toric II<br>* Toric Intraocular Lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit | Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method. | 1 week postoperative |