Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction

NCT ID: NCT01225952

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-07-31

Brief Summary

The objective of this study is to compare the contrast sensitivity, high and low contrast visual acuity (VA), glare meter outcomes, and subject satisfaction with three different FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near vision following lens extraction in adults at least 40 years of age.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Crystalens AO

Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens

Group Type: EXPERIMENTAL

Crystalens AO

Intervention Type: DEVICE

Bausch \& Lomb model silicone multi-piece accommodating IOL.

ReSTOR 3.0

An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.

Group Type: ACTIVE_COMPARATOR

ReSTOR 3.0

Intervention Type: DEVICE

An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.

AMO Tecnis Multifocal

A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL

Group Type: ACTIVE_COMPARATOR

AMO Tecnis Multifocal

Intervention Type: DEVICE

The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.

Interventions

Crystalens AO

Bausch \& Lomb model silicone multi-piece accommodating IOL.

Intervention Type: DEVICE

ReSTOR 3.0

An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.

Intervention Type: DEVICE

AMO Tecnis Multifocal

The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects must be undergoing primary IOL implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
• Subjects must require a spherical lens power from 10.00 diopters (D) to 33.00 D.
• Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes.
• Subjects must have stopped contact lens wear for at least two weeks for soft lens wearers or three weeks for gas permeable lens wearers prior to biometry and surgery.
• At the time of surgery, subjects must have an intact centered capsulorhexis, intact posterior capsule, and no zonular rupture.
• Subjects must have ≤ 1.25 D of preoperative corneal astigmatism in both eyes.

Exclusion Criteria

• Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level of 20/32 or worse.
• Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome.
• 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 uncontrolled glaucoma.
• Subjects with previous retinal detachment.
• Subjects with visually significant diabetic retinopathy (proliferative or nonproliferative) which reduces potential acuity to 20/32 or worse.
• Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract.
• Subjects with marked microphthalmos or aniridia.
• Subjects who have had previous corneal surgery.
• Subjects with irregular corneal astigmatism.
• Subjects with amblyopia which reduces potential acuity to 20/32 or worse.
• Subjects with optic atrophy.
• Subjects with iris neovascularization.
• Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/32 or worse.
• Subjects with chronic use of systemic steroids or immunosuppressive medications.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tes Ignacio, MD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Asian Eye Institute

Makati City, , Philippines

Countries

Philippines

Other Identifiers

656

Identifier Type: -

Identifier Source: org_study_id