Toric Intraocular Lens Following Cataract Surgery

Study Overview
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Brief Summary
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The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular lens (IOL) placement.

Official Title
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A Prospective Multicenter Clinical Trial To Evaluate the Effectiveness of A Toric Accommodating Posterior Chamber Silicone Intraocular Lens Designed To Provide Near, Intermediate, And Distance Vision And Reduce The Effects Of Preoperative Corneal Astigmatism On Postoperative Refraction Following Cataract Surgery

Conditions
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Cataract, Astigmatism

Intervention / Treatment
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* Device: Toric Accommodating Lens
* Device: Accommodating Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have a clinically documented diagnosis of age-related cataract Subjects must require a lens power from 16 to 27 diopters Subjects must have predicted post-operative corneal astigmatism between 0.83D and 2.50D, as determined by the Toric Calculator Exclusion Criteria: Subjects with any anterior segment pathology for which extracapsular/ phacoemulsification cataract surgery would be contraindicated. Subjects with diagnoses of degenerative visual disorders. Subjects with conditions associated with increased risk of zonular rupture. Subjects who have had previous corneal surgery in the planned operative eye. Subjects with irregular corneal astigmatism. Subjects with clinically significant retinal pigment or epithelium/macular changes. Subjects with chronic use of systemic steroids or immunosuppressive medications. Subjects either concurrently participating in another clinical trial or have participated in another clinical trial within 60 days prior to enrollment in this study. Subjects with a difference in corneal astigmatism measured with the IOL Master and the topographer greater than 0.5 D using vector analysis.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crystalens toric IOL<br>Toric Accommodating Lens Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T) | Device: Toric Accommodating Lens<br>* Toric accommodating lens implanted after cataract extraction<br>|
| Active Comparator: Crystalens IOL<br>Accommodating Lens Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE) | Device: Accommodating Lens<br>* Accommodating lens implanted after cataract extraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Reduction in Absolute Cylinder | Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error. | 120 - 180 day postoperative visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Misalignment | This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not. | 120 - 180 day postoperative visit | 
| Visual Acuity | Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR) | 120 - 180 day postoperative visit |