Evaluation of 3 Intraocular Lenses Following Lens Extraction

Bausch + Lomb

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Device: Tecnis Multifocal IOL; Device: ReSTOR; Device: Crystalens AO

Study type: Interventional

Funder types: Industry

Identifiers

NCT01122576

651

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 3 patient groups

Crystalens AO

Experimental group

Description:

Eligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally.

Treatment:

Device: Crystalens AO

ReSTOR

Active Comparator group

Description:

Eligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.

Treatment:

Device: ReSTOR

Tecnis Multifocal IOL

Active Comparator group

Description:

Eligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.

Treatment:

Device: Tecnis Multifocal IOL