Toric Intraocular Lens Following Cataract Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Astigmatism
• Intervention / Treatment: Device: Toric Accommodating Lens; Device: Accommodating Lens

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • B&L Surgical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Jay Pepose, MD, PhD, Pepose Vision Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: June 8, 2010
• First Submitted That Met QC Criteria: June 8, 2010
• First Posted (Estimate): June 9, 2010

Study Record Updates

• Last Update Posted (Estimate): September 8, 2014
• Last Update Submitted That Met QC Criteria: August 29, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: 650