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Toric Intraocular Lens Following Cataract Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01140477
First Posted: June 9, 2010
Last Update Posted: September 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01140477     History of Changes
Other Study ID Numbers: 650
First Submitted: June 8, 2010
First Posted: June 9, 2010
Results First Submitted: August 7, 2014
Results First Posted: August 22, 2014
Last Update Posted: September 8, 2014
Last Verified: August 2014

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