Toric Intraocular Lens Following Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract; Astigmatism
• Interventions: Device: Toric Accommodating Lens; Device: Accommodating Lens

• Registration Number: NCT01140477
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Primary Completion: 2011-12
• Study Completion: 2012-10
• Status Verified: 2014-08
• Results First Submitted: 2014-08-07
• Results First Submitted QC: 2014-08-07
• Results First Posted: 2014-08-22
• Last Update Submitted: 2014-08-29
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crystalens toric IOL	Toric Accommodating Lens	Toric Accommodating Lens Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
Crystalens IOL	Accommodating Lens	Accommodating Lens Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)

Primary Outcome Measures

Name	Time	Method
Percent Reduction in Absolute Cylinder	120 - 180 day postoperative visit	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

B&L Surgical; 🇺🇸 Bridgewater, New Jersey, United States