Evaluation of 3 Intraocular Lenses Following Lens Extraction

Completed · Phase 4

Conditions studied: Cataract

In brief

The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.

Key facts

Study ID

NCT01122576

Run by

Bausch & Lomb Incorporated

People needed

78

Starts

2010-06-01

Expected to finish

2012-09-01

Last updated by the study team

2014-03-28

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
• Subjects must require a spherical lens power from 10.00 D to 33.00 D
• Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter

You may not qualify if…

• Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens.
• Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
• Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.

Where it is running

• Bausch & Lomb, Inc — Aliso Viejo, California, United States

Full record on ClinicalTrials.gov

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