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

NCT01241279 | Terminated Phase 4 Results

• 1 other identifier: 657
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

cataract surgery; intraocular lens

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual Acuity

  All visits through visit 4 (day 160-180)

Study Arms (2)

Crystalens AO

EXPERIMENTAL

A silicone multi-piece accommodating intraocular lens

Device: Crystalens AO

SoftPort LI61AO

ACTIVE COMPARATOR

A silicone multi-piece foldable aspheric intraocular lens

Device: SoftPort LI61AO

Interventions

Crystalens AO 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.

Crystalens AO

SoftPort LI61AO 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.

SoftPort LI61AO

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Limitations and Caveats

Study terminated early due to lack of enrollment

Results Point of Contact

• Title: Johnson Varughese
• Organization: Valeant Pharmaceuticals/Bausch & Lomb

Johnson.Varughese@valeant.com

908-927-1162

Study Officials

• Johnson Varughese

  Valeant Pharmaceuticals/Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 16, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 26, 2014
• Results First Posted: November 26, 2014

Record last verified: 2014-11

Locations

US (1)