Toric Intraocular Lens Following Cataract Surgery

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140477
• Other study ID #: 650
• Status: Completed
• Phase: N/A
• First received: June 8, 2010
• Last updated: August 29, 2014
• Start date: June 2010
• Est. completion date: October 2012

Study information

• Verified date: August 2014
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: October 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Device:
• Toric Accommodating Lens
Toric accommodating lens implanted after cataract extraction
• Accommodating Lens
Accommodating lens implanted after cataract extraction

Locations

Country	Name	City	State
United States	B&L Surgical	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	120 - 180 day postoperative visit	No
Secondary	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.	120 - 180 day postoperative visit	No
Secondary	Visual Acuity	Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)	120 - 180 day postoperative visit	No