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CataractPhase 1NCT01714635

Clinical Investigation of Expanded Designs of a Multifocal IOL

A Phase 1 study testing Tecnis Multifocal Intraocular Lens and Monofocal Intraocular Lens in people with Cataract, run by Abbott Medical Optics at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cataract
What is being tested?
Tecnis Multifocal Intraocular Lens and Monofocal Intraocular Lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
445 participants
Where
18 sitesin 2 countries
Study dates
Nov 2012to Jul 2014
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

United States17 sites

  • Wallace Eye Surgery

    Alexandria, Louisiana, 71303

  • The Eye Center of Central PA

    Allenwood, Pennsylvania, 17810

  • Empire Eye & Laser Center

    Bakersfield, California, 93309

  • Assil Eye Institute

    Beverly Hills, California, 90210

  • Cape Coral Eye Center (Argus Research Center)

    Cape Coral, Florida, 33904

  • Pepose Vision Institute

    Chesterfield, Missouri, 63017

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania, 16066

  • Loden Vision Center

    Goodlettsville, Tennessee, 37072

  • Whitsett Vision Group

    Houston, Texas, 77055

  • Eye Surgeons of Indiana

    Indianapolis, Indiana, 46256

  • Clarus Eye Centre

    Lacey, Washington, 98503

  • Virdi Eye Clinic & Laser Vision Center

    Rock Island, Illinois, 61201

  • Ophthalmic Consultants of Long Island

    Rockville Centre, New York, 11570

  • Boozman-Hof Regional Eye Clinic

    Rogers, Arkansas, 72757

  • Lone Star Eye Care

    Sugar Land, Texas, 77479

  • Fishkind, Bakewell & Maltzman Eye Care & Surgery Center

    Tucson, Arizona, 85704

  • Bucci Cataract & Laser Vision

    Wilkes-Barre, Pennsylvania, 18702

Other trials in United States

United Kingdom1 site

  • The Midline Eye Institute

    Solihull, B91 2AW

Other trials in United Kingdom

About this study

Official title: Clinical Investigation of Expanded Designs of the Tecnis® Multifocal 1-Piece IOL

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.

Conditions
Cataract
Being tested
Tecnis Multifocal Intraocular Lens, Monofocal Intraocular Lens
Keywords
cataract, IOL, intraocular lens
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tecnis Multifocal Intraocular LensDevice

  • Monofocal Intraocular LensDevice

Study groups in NCT01714635
Study groupRoleWhat they receive
Tecnis Multifocal Intraocular lens #1ExperimentalA low diopter add multifocal intraocular lens
Receives: Device: Tecnis Multifocal Intraocular Lens
Tecnis Multifocal Intraocular Lens #2ExperimentalA low diopter add multifocal intraocular lens
Receives: Device: Tecnis Multifocal Intraocular Lens
Monofocal Intraocular LensActive comparatorCommercially available monofocal intraocular lens (IOL)
Receives: Device: Monofocal Intraocular Lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm

    Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative

    Measured: six months

Secondary outcomes (2)

  1. Mean Diopter Range With VA of 20/40 or Better

    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.

    Measured: six months

  2. Spectacle Independence

    Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionOct 2013
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
445 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01714635
Sponsor's protocol ID
DIOL-106-ZMLA
Status last verified
Nov 2014
First submitted
24 Oct 2012
Last updated
17 Mar 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tecnis Multifocal Intraocular Lens and Monofocal Intraocular Lens in people with Cataract, run by Abbott Medical Optics at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01714635.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.

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