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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01241279
First received: November 12, 2010
Last updated: August 10, 2012
Last verified: August 2012

November 12, 2010
August 10, 2012
November 2010
November 2011   (final data collection date for primary outcome measure)
Amplitude of accommodation [ Time Frame: Visit 4 (postoperative day 120-180) ] [ Designated as safety issue: No ]
The measurement of optical change in the power of the eye when viewing from far to near.
Same as current
Complete list of historical versions of study NCT01241279 on ClinicalTrials.gov Archive Site
Visual Acuity [ Time Frame: All visits through visit 4 (day 160-180) ] [ Designated as safety issue: No ]
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 intermdeiate and near visual acuity (VA). Visual acuity measured in LogMAR.
Visual Acuity [ Time Frame: All visits through visit 4 (day 160-180) ] [ Designated as safety issue: No ]
Number of correct letters on a ETDRS chart to measure distance visual acuity and the smallest readable print size on an MNREAD acuity chart for intermdeiate and near visual acuity (VA). Visual acuity measured in LogMAR.
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cataract
  • 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.
  • 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.
  • Experimental: Crystalens AO
    A silicone multi-piece accommodating intraocular lens
    Intervention: Device: Crystalens AO
  • Active Comparator: SoftPort LI61AO
    A silicone multi-piece foldable aspheric intraocular lens
    Intervention: Device: SoftPort LI61AO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
December 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01241279
657
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Omid Khodai, OD, RAC Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP