Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses

NCT ID: NCT01241279

Last Updated: 2014-11-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-12-31

Brief Summary

The objective of this study is to demonstrate the correlation of near vision and changes in higher order aberrations following lens extraction and to characterize the defocus curves of Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in adults.

Conditions

Cataract

Study Design

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

Study Groups

Crystalens AO

A silicone multi-piece accommodating intraocular lens

Group Type: EXPERIMENTAL

Crystalens AO

Intervention Type: DEVICE

Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the Crystalens AO intraocular lens.

SoftPort LI61AO

A silicone multi-piece foldable aspheric intraocular lens

Group Type: ACTIVE_COMPARATOR

SoftPort LI61AO

Intervention Type: DEVICE

Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the SoftPort LI61AO intraocular lens.

Interventions

Crystalens AO

Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the Crystalens AO intraocular lens.

Intervention Type: DEVICE

SoftPort LI61AO

Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the SoftPort LI61AO intraocular lens.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects must have clear intraocular media other than cataract.
• 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 be undergoing primary IOL implantation for the correction of aphakia following central continuous curvilinear anterior capsulorrhexis and phacoemulsification cataract extraction.
• Subjects must require a spherical lens power from 10.00 D to 30.00 D.
• Subjects must be willing and able to return for all scheduled follow-up examinations for each eye from days 1 through 180 following surgery.
• Subjects must have ≤ 1.25 D of preoperative corneal astigmatism.

Exclusion Criteria

• Subjects with corneal pathology potentially affecting topography.
• Subjects whose fundus cannot be assessed preoperatively.
• Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level worse than 20/30 as verified by OCT.
• 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 non-proliferative) which reduces potential acuity to 20/30 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 worse than 20/30.
• Subjects with optic atrophy.
• Subjects with iris neovascularization.
• Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/30 or worse.
• Subjects with chronic use of systemic steroids or immunosuppressive medications.
• Subjects lacking intact binocular vision.

• 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

Johnson Varughese

Role: STUDY_DIRECTOR

Valeant Pharmaceuticals/Bausch & Lomb Incorporated

Locations

Bausch & Lomb

Irvine, California, United States

Countries

United States

Other Identifiers

657

Identifier Type: -

Identifier Source: org_study_id