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

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

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 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
Primary Completion Date : November 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

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.



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.



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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241279


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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01241279     History of Changes
Other Study ID Numbers: 657
First Posted: November 16, 2010    Key Record Dates
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