Toric Intraocular Lens Following Cataract Surgery

NCT ID: NCT01140477

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 229 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-10-31

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.

Conditions

Cataract; Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Crystalens toric IOL

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

Group Type: EXPERIMENTAL

Toric Accommodating Lens

Intervention Type: DEVICE

Toric accommodating lens implanted after cataract extraction

Crystalens IOL

Accommodating Lens Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)

Group Type: ACTIVE_COMPARATOR

Accommodating Lens

Intervention Type: DEVICE

Accommodating lens implanted after cataract extraction

Interventions

Toric Accommodating Lens

Toric accommodating lens implanted after cataract extraction

Intervention Type: DEVICE

Accommodating Lens

Accommodating lens implanted after cataract extraction

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay Pepose, MD, PhD

Role: STUDY_DIRECTOR

Pepose Vision Institute

Locations

B&L Surgical

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

650

Identifier Type: -

Identifier Source: org_study_id