Clinical Investigation of the Next-Generation Intraocular Lens

NCT03111550 | Completed Results FDA Device

• 1 other identifier: EDOF-121-NGPC
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 12

Brief Summary

This study is a 6-month, prospective, multicenter, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL. The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

• Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm

  The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative

  1 month postoperative

• Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)

  Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO (International Organization for Standardization) SPE (Safety and performance Endpoint) rates using a one-sided, exact test based on the binomial distribution. ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). ISO 11979-7 is a document that specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia. SPE rate: safety and performance endpoint (rate derived from analysis of the data from clinical investigations of IOLs approved in the US). Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.

  6 months postoperative

• Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)

  Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO SPE rates using a one-sided, exact test based on the binomial distribution. Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.

  6 months postoperative

Study Arms (3)

Investigational Lens Device #1

OTHER

Investigational Intraocular Lens Device #1: Tecnis Model ZHR00

Device: Investigational Intraocular Lens Device #1: TECNIS Model ZHR00

Investigational Lens Device #2

OTHER

Investigational Intraocular Lens Device #2: Tecnis Model ZQR00

Device: Investigational Intraocular Lens Device #2: TECNIS Model ZQR00

Control Device

OTHER

Control TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00

Device: TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00

Interventions

Investigational Intraocular Lens Device #1: TECNIS Model ZHR00 DEVICE

Intraocular lens replaces the natural lens removed during cataract surgery.

Investigational Lens Device #1

Investigational Intraocular Lens Device #2: TECNIS Model ZQR00 DEVICE

Intraocular lens replaces the natural lens removed during cataract surgery.

Investigational Lens Device #2

TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00 DEVICE

Intraocular lens replaces the natural lens removed during cataract surgery.

Control Device

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral cataracts
• Potential for postoperative BCDVA of 20/30 Snellen or better
• Corneal astigmatism of 1.00 D or less in both eyes
• Normal corneal topography
• Clear intraocular media other than cataract in each eye
• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries

You may not qualify if:

• 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
• 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
• 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
• 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 of tamsulosin or silodosin
• Poorly-controlled diabetes
• Acute, chronic, or uncontrolled systemic or ocular disease or illness
• Known ocular disease or pathology that may affect visual acuity or may require surgical intervention during the course of the study or may be expected to require retinal laser treatment or other surgical intervention during the course of the study
• 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

Sponsors & Collaborators

• Abbott Medical Optics: lead

Study Sites (12)

Empire Eye and Laser Center

Bakersfield, California, 93309, United States

Location

Assil Eye Institute

Beverly Hills, California, 90210, United States

Location

Jones Eye Care

Sioux City, Iowa, 51104, United States

Location

Chesapeake Eye Care and Laser

Annapolis, Maryland, 21401, United States

Location

Eye Doctors of Washington

Chevy Chase, Maryland, 20815, United States

Location

Ophthalmology Consultants LTD

St Louis, Missouri, 63131, United States

Location

Scott and Christie and Associates,PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Carolina Cataract and Laser Center

Ladson, South Carolina, 29456, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Loden Vision Centers

Goodlettsville, Tennessee, 37072, United States

Location

Key-Whitman Eye Center

Dallas, Texas, 75243, United States

Location

Texas Eye and Laser Center

Hurst, Texas, 76054, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Devi Priya Janakiraman,OD, FAAO
• Organization: Johnson & Johnson Surgical Vision

djanaki1@its.jnj.com

+1 714-247-8628

Study Officials

• Devi Priya Janakiraman, OD,FAAO

  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
• Masking Details: subject/evaluator-masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 13, 2017
• Study Start: May 10, 2017
• Primary Completion: February 23, 2018
• Study Completion: February 23, 2018
• Last Updated: June 24, 2025
• Results First Posted: August 24, 2020

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)