Clinical Investigation of Expanded Designs of a Multifocal IOL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01714635
Recruitment Status : Completed
First Posted : October 26, 2012
Results First Posted : January 15, 2015
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.

Condition or disease Intervention/treatment Phase
Cataract Device: Tecnis Multifocal Intraocular Lens Device: Monofocal Intraocular Lens Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Investigation of Expanded Designs of the Tecnis® Multifocal 1-Piece IOL
Study Start Date : November 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tecnis Multifocal Intraocular lens #1
A low diopter add multifocal intraocular lens
Device: Tecnis Multifocal Intraocular Lens
Experimental: Tecnis Multifocal Intraocular Lens #2
A low diopter add multifocal intraocular lens
Device: Tecnis Multifocal Intraocular Lens
Active Comparator: Monofocal Intraocular Lens
Commercially available monofocal intraocular lens (IOL)
Device: Monofocal Intraocular Lens

Primary Outcome Measures :
  1. Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm [ Time Frame: six months ]
    Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative

Secondary Outcome Measures :
  1. Mean Diopter Range With VA of 20/40 or Better [ Time Frame: six months ]

    Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately*) to reach the 6-month visit were included in the substudy.

    * The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively.

  2. Spectacle Independence [ Time Frame: six months ]
    Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Minimum 18 years of age
  • Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
  • Preoperative best-corrected distance visual acuity (BCDVA) of 20/40 or worse (Snellen) with or without a glare source
  • Potential for postoperative best-corrected visual acuity of 20/25 or better
  • Preoperative corneal astigmatism of 1.0 D or less with normal corneal topography and no irregular corneal astigmatism
  • Clear intraocular media, other than cataract
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
  • Ability to understand and respond to a questionnaire verbally administered in English

Exclusion Criteria:

  • Requiring an intraocular lens power outside the available range of +16.0 to +28.0 D
  • Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
  • Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes
  • Prior refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
  • Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study
  • Inability to achieve keratometric stability for contact lens wearers
  • Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study
  • Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
  • Use of systemic or ocular medications that may affect vision
  • Prior, current, or anticipated use during the course of the 12-month study of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery
  • Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
  • Poorly-controlled diabetes
  • Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: ocular hypertension without glaucomatous changes is acceptable.
  • Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
  • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
  • Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial
  • Desire for monovision correction

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 identifier (NCT number): NCT01714635

United States, Arizona
Fishkind, Bakewell & Maltzman Eye Care & Surgery Center
Tucson, Arizona, United States, 85704
United States, Arkansas
Boozman-Hof Regional Eye Clinic
Rogers, Arkansas, United States, 72757
United States, California
Empire Eye & Laser Center
Bakersfield, California, United States, 93309
Assil Eye Institute
Beverly Hills, California, United States, 90210
United States, Florida
Cape Coral Eye Center (Argus Research Center)
Cape Coral, Florida, United States, 33904
United States, Illinois
Virdi Eye Clinic & Laser Vision Center
Rock Island, Illinois, United States, 61201
United States, Indiana
Eye Surgeons of Indiana
Indianapolis, Indiana, United States, 46256
United States, Louisiana
Wallace Eye Surgery
Alexandria, Louisiana, United States, 71303
United States, Missouri
Pepose Vision Institute
Chesterfield, Missouri, United States, 63017
United States, New York
Ophthalmic Consultants of Long Island
Rockville Center, New York, United States, 11570
United States, Pennsylvania
The Eye Center of Central PA
Allenwood, Pennsylvania, United States, 17810
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States, 16066
Bucci Cataract & Laser Vision
Wilkes Barre, Pennsylvania, United States, 18702
United States, Tennessee
Loden Vision Center
Goodlettsville, Tennessee, United States, 37072
United States, Texas
Whitsett Vision Group
Houston, Texas, United States, 77055
Lone Star Eye Care
Sugar Land, Texas, United States, 77479
United States, Washington
Clarus Eye Centre
Lacey, Washington, United States, 98503
United Kingdom
The Midline Eye Institute
Solihull, United Kingdom, B91 2AW
Sponsors and Collaborators
Abbott Medical Optics
Study Director: Kendra Hileman, PhD Abbott Medical Optics

Responsible Party: Abbott Medical Optics Identifier: NCT01714635     History of Changes
Other Study ID Numbers: DIOL-106-ZMLA
First Posted: October 26, 2012    Key Record Dates
Results First Posted: January 15, 2015
Last Update Posted: March 17, 2015
Last Verified: November 2014

Keywords provided by Abbott Medical Optics:
intraocular lens

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases