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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
  Purpose

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 Intervention Phase
Cataract
Device: Crystalens AO
Device: SoftPort LI61AO
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 7
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241279

Locations
United States, California
Bausch & Lomb
Aliso Viejo, California, United States, 92657
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Omid Khodai, OD, RAC Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01241279     History of Changes
Other Study ID Numbers: 657
Study First Received: November 12, 2010
Last Updated: August 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
cataract surgery
intraocular lens

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on November 20, 2014