CompletedNCT03372434Updated Jun 24, 2025Results posted

Clinical Investigation of the Next-Generation Intraocular Lenses

An interventional study of Investigational Intraocular Lens Device #1: Model ZFR00 and Investigational Intraocular Lens Device #1: Model ZYR00 in Cataract, sponsored by Abbott Medical Optics. Completed at 12 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by Abbott Medical Optics (formerly part of Abbott) · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 225
Allocation: Randomized
Ages: 22 Years and older
Sex: All

Study 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.

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 studied

Cataract

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Cataract 1,629

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's enrollment of 225 is above the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Abbott Medical Optics is the lead sponsor of 35 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.

First submitted after Abbott Medical Optics left Abbott.

Browse Abbott Medical Optics studies →All Abbott studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 22 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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
- 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 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

Exclusion criteria

Exclusion Criteria:

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
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., , 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 225 participants (actual)

Study arms

Experimental
Investigational Lens Device #1
Investigational Intraocular Lens Device #1: Model ZFR00
Device: Investigational Intraocular Lens Device #1: Model ZFR00
Experimental
Investigational Lens Device #2
Investigational Intraocular Lens Device #1: Model ZYR00
Device: Investigational Intraocular Lens Device #1: Model ZYR00
Active comparator
Control Device
Control TECNIS Multifocal Intraocular Lens Model ZLB00
Device: TECNIS Multifocal Intraocular Lens: Model ZLB00

Interventions

DeviceInvestigational Intraocular Lens Device #1: Model ZFR00
IOL replaces the natural lens removed during cataract surgery.
DeviceInvestigational Intraocular Lens Device #1: Model ZYR00
IOL replaces the natural lens removed during cataract surgery.
DeviceTECNIS Multifocal Intraocular Lens: Model ZLB00
IOL replaces the natural lens removed during cataract surgery.

What researchers measure

Primary outcomes

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.
Time frame: 1 month

Results

Posted Jul 27, 2021

Participant flow

Participant flow — Overall Study
Milestone	Model ZFR00	Model ZLB00	Model ZYR00
Started	78	73	74
1 month follow-up	76	72	73
Completed	76	70	72
Not completed	2	3	2

Outcome measures

PrimaryDistance 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.

Time frame:: 1 month
Reported as:: Mean · LogMAR

Distance Corrected Intermediate Visual Acuity
LogMAR	Model ZFR00	Model ZLB00	Model ZYR00
Distance Corrected Intermediate Visual Acuity	0.098 ± 0.115	0.219 ± 0.146	0.147 ± 0.149

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Model ZFR00	0/78 (0%)	5/78 (6.4%)	6/78 (7.7%)
Model ZLB00	0/73 (0%)	13/73 (17.8%)	1/73 (1.4%)
Model ZYR00	0/74 (0%)	4/74 (5.4%)	3/74 (4.1%)

Most frequent serious events

Showing 10 of 16

Most frequent serious events
Event	Model ZFR00	Model ZLB00	Model ZYR00
HospitalizationGeneral disorders	0/78	3/73	1/74
Cystoid Macular EdemaEye disorders	0/78	0/73	2/74
Macular HoleEye disorders	0/78	1/73	0/74
Bothersome Visual SymptomProduct Issues	1/78	1/73	1/74
Herpes Zoster KeratitisEye disorders	0/78	1/73	0/74
Haptic anterior to capsule bagEye disorders	0/78	1/73	0/74
Retinal HoleEye disorders	0/78	1/73	0/74
Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/78	1/73	0/74
Patent Foramen OvaleCardiac disorders	0/78	1/73	0/74
AngioplastyCardiac disorders	0/78	1/73	0/74

Most frequent other events

Most frequent other events
Event	Model ZFR00	Model ZLB00	Model ZYR00
Bothersome visual symptomProduct Issues	6/78	1/73	3/74

Baseline characteristics

Age, Customized
Age, Customized(Participants)	Model ZFR00	Model ZLB00	Model ZYR00	Total
Less than <60 years	10	13	17	40
60-69 years	38	35	34	107
70-79 years	27	23	21	71
Greater than or equal to >/80 years	3	2	2	7
Not reported	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Model ZFR00	Model ZLB00	Model ZYR00	Total
Female	54	48	49	151
Male	24	25	25	74

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Model ZFR00	Model ZLB00	Model ZYR00	Total
Hispanic or Latino	4	6	3	13
Not Hispanic or Latino	74	67	71	212
Unknown or Not Reported	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Model ZFR00	Model ZLB00	Model ZYR00	Total
Asian (including Indian)	0	3	0	3
Black	3	7	7	17
Native Hawaiian/Pacific Islander	0	0	0	0
Caucasian	75	62	66	203
Another Race	0	1	0	1
Not reported	0	0	1	1

Study locations

12 sites

Empire Eye & Laser Center
Bakersfield, California 93309, United States
Katzen Eye Care and Laser Center
Boynton Beach, Florida 33426, United States
Chesapeake Eye Care & Laser Center
Annapolis, Maryland 21401, United States
Eye Doctors of Washington
Chevy Chase, Maryland 20815, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania 16066, United States
Carolina EyeCare Physicians, LLC
Mt. Pleasant, South Carolina 29464, United States
Loden Vision Centers
Goodlettsville, Tennessee 37072, United States
Eye Specialty Group
Memphis, Tennessee 38120, United States
Texas Eye and Laser Center
Hurst, Texas 76054, United States
Lehmann Eye Center
Nacogdoches, Texas 75965, United States
Focal Point Vision
San Antonio, Texas 78209, United States
Clarus Eye Centre
Lacey, Washington 98503, United States

References and documents

Study documents

Study protocol ↗ · Dec 14, 2017
Statistical analysis plan ↗ · May 16, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Jul 2018, 5 months.

Results were first posted in Jul 2021, 3 years after primary completion. A results delay was requested in Nov 2019.

Of 190 industry-sponsored interventional studies with no phase under Cataract, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's 5 months is below that.

Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 8, 2017
First posted: Dec 13, 2017
StartActual: Jan 16, 2018
Primary completionActual: Jul 11, 2018
CompletionActual: Oct 30, 2018
Results delay requested: Nov 7, 2019
Results first posted: Jul 27, 2021
Last update: Jun 24, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03372434
Lead sponsor: Abbott Medical Optics
Responsible party: Sponsor
First posted: Dec 13, 2017
Start date: Jan 16, 2018
Primary completion: Jul 11, 2018
Completion: Oct 30, 2018
Results posted: Jul 27, 2021
Last update: Jun 24, 2025

Study contacts

Abbott Medical Optics Clinical Trials

study director · Abbott Medical Optics

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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