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Toric Intraocular Lens Following Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01140477
First received: June 8, 2010
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cataract
Astigmatism
Device: Toric Accommodating Lens
Device: Accommodating Lens

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Percent Reduction in Absolute Cylinder [ Time Frame: 120 - 180 day postoperative visit ] [ Designated as safety issue: No ]
    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:
  • Lens Misalignment [ Time Frame: 120 - 180 day postoperative visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: 120 - 180 day postoperative visit ] [ Designated as safety issue: No ]
    Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)


Enrollment: 229
Study Start Date: June 2010
Study Completion Date: October 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140477

Locations
United States, New Jersey
B&L Surgical
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Jay Pepose, MD, PhD Pepose Vision Institute
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01140477     History of Changes
Other Study ID Numbers: 650
Study First Received: June 8, 2010
Results First Received: August 7, 2014
Last Updated: August 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Astigmatism
Cataract
Eye Diseases
Lens Diseases
Refractive Errors

ClinicalTrials.gov processed this record on November 20, 2014