Evaluation of 3 Intraocular Lenses Following Lens Extraction

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Crystalens AO

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

Group Type EXPERIMENTAL

Crystalens AO

Intervention Type DEVICE

Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.

ReSTOR

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

Group Type ACTIVE_COMPARATOR

ReSTOR

Intervention Type DEVICE

ReSTOR surgically implanted bilaterally. Study observation up to 180 days.

Tecnis Multifocal IOL

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

Group Type ACTIVE_COMPARATOR

Tecnis Multifocal IOL

Intervention Type DEVICE

Tecnis surgically implanted bilaterally. Study observation up to 180 days.

Interventions

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Crystalens AO

Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.

Intervention Type DEVICE

ReSTOR

ReSTOR surgically implanted bilaterally. Study observation up to 180 days.

Intervention Type DEVICE

Tecnis Multifocal IOL

Tecnis surgically implanted bilaterally. Study observation up to 180 days.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No