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

Bausch + Lomb

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Device: AMO Tecnis Multifocal; Device: ReSTOR 3.0; Device: Crystalens AO

Study type: Interventional

Funder types: Industry

Identifiers

NCT01225952

656 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

93 participants in 3 patient groups

Crystalens AO

Experimental group

Description:

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

Treatment:

Device: Crystalens AO

ReSTOR 3.0

Active Comparator group

Description:

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

Treatment:

Device: ReSTOR 3.0

AMO Tecnis Multifocal

Active Comparator group

Description:

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

Treatment:

Device: AMO Tecnis Multifocal