Back to resultsToric Intraocular Lens Following Cataract Surgery
Primary Purpose
Cataract, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Toric Accommodating Lens
Accommodating Lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
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.
Sites / Locations
- B&L Surgical
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Crystalens toric IOL
Crystalens IOL
Arm Description
Toric Accommodating Lens Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
Accommodating Lens Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Visual Acuity
Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)
Full Information
NCT ID
NCT01140477
First Posted
June 8, 2010
Last Updated
August 29, 2014
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01140477
Brief Title
Toric Intraocular Lens Following Cataract Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
229 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crystalens toric IOL
Arm Type
Experimental
Arm Description
Toric Accommodating Lens Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
Arm Title
Crystalens IOL
Arm Type
Active Comparator
Arm Description
Accommodating Lens Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
Intervention Type
Device
Intervention Name(s)
Toric Accommodating Lens
Intervention Description
Toric accommodating lens implanted after cataract extraction
Intervention Type
Device
Intervention Name(s)
Accommodating Lens
Intervention Description
Accommodating lens implanted after cataract extraction
Primary Outcome Measure Information:
Title
Percent Reduction in Absolute Cylinder
Description
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.
Time Frame
120 - 180 day postoperative visit
Secondary Outcome Measure Information:
Title
Lens Misalignment
Description
This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not.
Time Frame
120 - 180 day postoperative visit
Title
Visual Acuity
Description
Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)
Time Frame
120 - 180 day postoperative visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Pepose, MD, PhD
Organizational Affiliation
Pepose Vision Institute
Official's Role
Study Director
Facility Information:
Facility Name
B&L Surgical
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Toric Intraocular Lens Following Cataract Surgery
We'll reach out to this number within 24 hrs