Clinical Investigation of Expanded Designs of a Multifocal IOL

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01714635
First received: October 24, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Cataract
Device: Tecnis Multifocal Intraocular Lens
Device: Monofocal Intraocular Lens
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Investigation of Expanded Designs of the Tecnis® Multifocal 1-Piece IOL

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Distance-corrected near visual acuity (VA) under photopic conditions for both higher-add and lower add lens models [ Time Frame: six months ] [ Designated as safety issue: No ]
    Mean (LogMAR) monocular distance-corrected near visual acuity under photopic conditions at 40 cm at six months postoperative


Secondary Outcome Measures:
  • Mean binocular best-corrected depth-of-focus [ Time Frame: six months ] [ Designated as safety issue: No ]
    Mean binocular, best-corrected depth-of-focus (defined as the maximum diopters of defocus at which 20/40 or better visual acuity is achieved) at six months postoperative for both higher-add lens model and lower-add lens model

  • Spectacle independence [ Time Frame: six months ] [ Designated as safety issue: No ]
    Proportion of subjects achieving spectacle independence at six months for both the higher-add and lower-add lens models.

  • Combined best-corrected distance visual acuity (BCDVA) and distance-corrected near visual acuity (DCNVA) [ Time Frame: six months ] [ Designated as safety issue: No ]
    Proportion of subjects achieving combined best-corrected distance visual acuity (binocular BCDVA 20/25 or better) and distance-corrected near visual acuity (binocular DCNVA 20/32 or better) at six months postoperative for both higher-add and lower-add lens models


Other Outcome Measures:
  • Adverse events [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Postoperative complication and adverse event rates vs. ISO SPE rates


Estimated Enrollment: 450
Study Start Date: November 2012
Study Completion Date: July 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01714635

Locations
United States, Indiana
Eye Surgeons of Indiana
Indianapolis, Indiana, United States, 46256
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Study Director: Kendra Hileman, PhD Abbott Medical Optics
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01714635     History of Changes
Other Study ID Numbers: DIOL-106-ZMLA
Study First Received: October 24, 2012
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Medical Optics:
cataract
IOL
intraocular lens

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014