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

• ClinicalTrials.gov Identifier: NCT01241279
• Recruitment Status: Terminated
• First Posted: November 16, 2010
• Results First Posted: November 26, 2014
• Last Update Posted: November 26, 2014
• Sponsor: Bausch & Lomb Incorporated
• Information provided by (Responsible Party): Bausch & Lomb Incorporated

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cataract	Device: Crystalens AO; Device: SoftPort LI61AO	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Two Arm Prospective, Randomized, Double-Masked Clinical Evaluation of Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
• Study Start Date: October 2010
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Visual Acuity [ Time Frame: All visits through visit 4 (day 160-180) ]
   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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, California

Bausch & Lomb

Irvine, California, United States, 92618

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

• Study Director: Johnson Varughese; Valeant Pharmaceuticals/Bausch & Lomb Incorporated

More Information

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01241279
• Other Study ID Numbers: 657
• First Posted: November 16, 2010
• Results First Posted: November 26, 2014
• Last Update Posted: November 26, 2014
• Last Verified: November 2014

Keywords provided by Bausch & Lomb Incorporated:

cataract surgery; intraocular lens

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases