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

A Two Arm Prospective, Randomized, Double-Masked Clinical Evaluation of Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses

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.

Study Overview

• Status: Terminated
• Conditions: Cataract
• Intervention / Treatment: Device: Crystalens AO; Device: SoftPort LI61AO

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Bausch & Lomb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crystalens AO; A silicone multi-piece accommodating intraocular lens	Device: 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.
Active Comparator: SoftPort LI61AO; A silicone multi-piece foldable aspheric intraocular lens	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amplitude of Accommodation	The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.	Visit 4 (postoperative day 120-180)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR.	All visits through visit 4 (day 160-180)

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 12, 2010
• First Submitted That Met QC Criteria: November 12, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Estimate): November 26, 2014
• Last Update Submitted That Met QC Criteria: November 25, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: intraocular lens; cataract surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 657

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No