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OpenTrials
Completed

NCT Number: NCT01140477

Toric Intraocular Lens 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.

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Key information

Conditions

Cataract Astigmatism Eye Diseases Lens Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

B&L Surgical

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Toric Accommodating Lens

Device

Toric accommodating lens implanted after cataract extraction

Accommodating Lens

Device

Accommodating lens implanted after cataract extraction

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Visual Acuity

    Time frame: 120 - 180 day postoperative visit

    Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 9, 2010
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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