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CataractNCT03372434

Clinical Investigation of the Next-Generation Intraocular Lenses

A study testing Investigational Intraocular Lens Device #1: Model ZFR00, Investigational Intraocular Lens Device #1: Model ZYR00 and TECNIS Multifocal Intraocular Lens: Model ZLB00 in people with Cataract, run by Abbott Medical Optics at 12 sites in United States.

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

This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL. Read more about this study

Who is it for?
Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for
Cataract
What is being tested?
Investigational Intraocular Lens Device #1: Model ZFR00, Investigational Intraocular Lens Device #1: Model ZYR00 and TECNIS Multifocal Intraocular Lens: Model ZLB00
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
12 sitesUnited States
Study dates
16 Jan 2018to 30 Oct 2018
Phase
Interventional
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 22 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Minimum 22 years of age
  • Bilateral cataracts for which posterior chamber IOL implantation has been planned
  • Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with a glare source or 20/40 Snellen or worse without a glare source
  • Potential for postoperative BCDVA of 20/30 Snellen or better
  • Corneal astigmatism:
  • Normal corneal topography
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  • Preoperative corneal astigmatism of 1.00 D or less in both eyes
  • Clear intraocular media other than cataract in each eye
  • 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 in English

Who cannot join

  • Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D
  • Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils)
  • Irregular corneal astigmatism
  • Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
  • Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery. Note: Prophylactic peripheral iridotomies and peripheral laser retinal repairs that, in the opinion of the investigator will not confound study outcome or increase risk to the subject, are acceptable.
  • Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
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  • Inability to achieve keratometric stability for contact lens wearers (per procedure outlined in Section 10.3)
  • Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
  • 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 worse than 20/30 Snellen during the study
  • Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as 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 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
  • 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 outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
  • Known ocular disease or pathology that, in the opinion of the investigator,
  • may affect visual acuity
  • may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.)
  • 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 60 days prior to preoperative visit in any other clinical trial
  • Desire for monovision correction

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Chesapeake Eye Care & Laser Center

    Annapolis, Maryland, 21401

  • Empire Eye & Laser Center

    Bakersfield, California, 93309

  • Katzen Eye Care and Laser Center

    Boynton Beach, Florida, 33426

  • Eye Doctors of Washington

    Chevy Chase, Maryland, 20815

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania, 16066

  • Loden Vision Centers

    Goodlettsville, Tennessee, 37072

  • Texas Eye and Laser Center

    Hurst, Texas, 76054

  • Clarus Eye Centre

    Lacey, Washington, 98503

  • Eye Specialty Group

    Memphis, Tennessee, 38120

  • Carolina EyeCare Physicians, LLC

    Mt. Pleasant, South Carolina, 29464

  • Lehmann Eye Center

    Nacogdoches, Texas, 75965

  • Focal Point Vision

    San Antonio, Texas, 78209

Other trials in United States

About this study

Official title: Clinical Investigation of the TECNIS Next-Generation Intraocular Lens

This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL.

The study will be conducted at up to 14 sites in the U.S.A and will enroll up to 260 subjects to achieve approximately 220 randomized and bilaterally-implanted subjects, resulting in approximately 195 evaluable subjects (65 in each test group and 65 in the control group) at 1 and 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZFR00 IOL, the ZYR00 IOL or the ZLB00 control IOL. The eye implanted first will be considered the primary study eye.

Conditions
Cataract
Being tested
Investigational Intraocular Lens Device #1: Model ZFR00, Investigational Intraocular Lens Device #1: Model ZYR00, TECNIS Multifocal Intraocular Lens: Model ZLB00
Medical subject headings
Cataract

What participants receive

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

  • Investigational Intraocular Lens Device #1: Model ZFR00Device

    IOL replaces the natural lens removed during cataract surgery.

  • Investigational Intraocular Lens Device #1: Model ZYR00Device

    IOL replaces the natural lens removed during cataract surgery.

  • TECNIS Multifocal Intraocular Lens: Model ZLB00Device

    IOL replaces the natural lens removed during cataract surgery.

Study groups in NCT03372434
Study groupRoleWhat they receive
Investigational Lens Device #1ExperimentalInvestigational Intraocular Lens Device #1: Model ZFR00
Receives: Device: Investigational Intraocular Lens Device #1: Model ZFR00
Investigational Lens Device #2ExperimentalInvestigational Intraocular Lens Device #1: Model ZYR00
Receives: Device: Investigational Intraocular Lens Device #1: Model ZYR00
Control DeviceActive comparatorControl TECNIS Multifocal Intraocular Lens Model ZLB00
Receives: Device: TECNIS Multifocal Intraocular Lens: Model ZLB00

What is being measured

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

  1. Distance Corrected Intermediate Visual Acuity

    Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.

    Measured: 1 month

Timeline

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

  1. First posted13 Dec 2017
  2. Study start16 Jan 2018
  3. Primary completion11 Jul 2018
  4. Study completion30 Oct 2018

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03372434
Sponsor's protocol ID
SUR-CAT-652-1001
Status last verified
Jun 2025
First submitted
8 Dec 2017
Last updated
24 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Investigational Intraocular Lens Device #1: Model ZFR00, Investigational Intraocular Lens Device #1: Model ZYR00 and TECNIS Multifocal Intraocular Lens: Model ZLB00 in people with Cataract, run by Abbott Medical Optics at 12 sites in United States.

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 11 inclusion and 21 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2021). 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?

Distance Corrected Intermediate Visual Acuity (time frame: 1 month). 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 NCT03372434.

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 24 Jun 2025.

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