Clinical Investigation of the Next-Generation Intraocular Lenses

NCT03372434 | Completed Results FDA Device

• 1 other identifier: SUR-CAT-652-1001
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 12

Brief 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

Cataract

Outcome Measures

Primary Outcomes (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.

  1 month

Study Arms (3)

Investigational Lens Device #1

EXPERIMENTAL

Investigational Intraocular Lens Device #1: Model ZFR00

Device: Investigational Intraocular Lens Device #1: Model ZFR00

Investigational Lens Device #2

EXPERIMENTAL

Investigational Intraocular Lens Device #1: Model ZYR00

Device: Investigational Intraocular Lens Device #1: Model ZYR00

Control Device

ACTIVE COMPARATOR

Control TECNIS Multifocal Intraocular Lens Model ZLB00

Device: TECNIS Multifocal Intraocular Lens: Model ZLB00

Interventions

Investigational Intraocular Lens Device #1: Model ZFR00 DEVICE

IOL replaces the natural lens removed during cataract surgery.

Investigational Lens Device #1

Investigational Intraocular Lens Device #1: Model ZYR00 DEVICE

IOL replaces the natural lens removed during cataract surgery.

Investigational Lens Device #2

TECNIS Multifocal Intraocular Lens: Model ZLB00 DEVICE

IOL replaces the natural lens removed during cataract surgery.

Control Device

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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., 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,

Sponsors & Collaborators

• Abbott Medical Optics: lead

Study Sites (12)

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Katzen Eye Care and Laser Center

Boynton Beach, Florida, 33426, United States

Location

Chesapeake Eye Care & Laser Center

Annapolis, Maryland, 21401, United States

Location

Eye Doctors of Washington

Chevy Chase, Maryland, 20815, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Carolina EyeCare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

Loden Vision Centers

Goodlettsville, Tennessee, 37072, United States

Location

Eye Specialty Group

Memphis, Tennessee, 38120, United States

Location

Texas Eye and Laser Center

Hurst, Texas, 76054, United States

Location

Lehmann Eye Center

Nacogdoches, Texas, 75965, United States

Location

Focal Point Vision

San Antonio, Texas, 78209, United States

Location

Clarus Eye Centre

Lacey, Washington, 98503, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Eugenia Thomas, OD
• Organization: Johnson & Johnson Surgical Vision

EThoma39@its.jnj.com

+1 657 2903260

Study Officials

• Abbott Medical Optics Clinical Trials

  Abbott Medical Optics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: January 16, 2018
• Primary Completion: July 11, 2018
• Study Completion: October 30, 2018
• Last Updated: June 24, 2025
• Results First Posted: July 27, 2021

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)