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

Bausch & Lomb Incorporated1 site in 1 country6 target enrollmentOctober 2010

ConditionsCataract

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Cataract
Sponsor: Bausch & Lomb Incorporated
Enrollment: 6
Locations: 1
Primary Endpoint: Amplitude of Accommodation
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

December 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Amplitude of Accommodation

Time Frame: Visit 4 (postoperative day 120-180)

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.