CataractNCT03111550

Clinical Investigation of the Next-Generation Intraocular Lens

A study testing Investigational Intraocular Lens Device #1: TECNIS Model ZHR00, Investigational Intraocular Lens Device #2: TECNIS Model ZQR00 and TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00 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, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Cataract
What is being tested?: Investigational Intraocular Lens Device #1: TECNIS Model ZHR00, Investigational Intraocular Lens Device #2: TECNIS Model ZQR00 and TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 242 participants
Where: 12 sitesUnited States
Study dates: 10 May 2017to 23 Feb 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
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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
Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial
Desire for monovision correction

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Chesapeake Eye Care and Laser
Annapolis, Maryland, 21401
Empire Eye and Laser Center
Bakersfield, California, 93309
Assil Eye Institute
Beverly Hills, California, 90210
Eye Doctors of Washington
Chevy Chase, Maryland, 20815
Scott and Christie and Associates,PC
Cranberry Township, Pennsylvania, 16066
Key-Whitman Eye Center
Dallas, Texas, 75243
Loden Vision Centers
Goodlettsville, Tennessee, 37072
Texas Eye and Laser Center
Hurst, Texas, 76054
Carolina Cataract and Laser Center
Ladson, South Carolina, 29456
Jones Eye Care
Sioux City, Iowa, 51104
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Ophthalmology Consultants LTD
St Louis, Missouri, 63131

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, 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
Being tested: Investigational Intraocular Lens Device #1: TECNIS Model ZHR00, Investigational Intraocular Lens Device #2: TECNIS Model ZQR00, TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00
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: TECNIS Model ZHR00Device
Intraocular lens replaces the natural lens removed during cataract surgery.
Investigational Intraocular Lens Device #2: TECNIS Model ZQR00Device
Intraocular lens replaces the natural lens removed during cataract surgery.
TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00Device
Intraocular lens replaces the natural lens removed during cataract surgery.

Study groups in NCT03111550
Study group	Role	What they receive
Investigational Lens Device #1	Other	Investigational Intraocular Lens Device #1: Tecnis Model ZHR00 Receives: Device: Investigational Intraocular Lens Device #1: TECNIS Model ZHR00
Investigational Lens Device #2	Other	Investigational Intraocular Lens Device #2: Tecnis Model ZQR00 Receives: Device: Investigational Intraocular Lens Device #2: TECNIS Model ZQR00
Control Device	Other	Control TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00 Receives: Device: TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00

What is being measured

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

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
Measured: 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.
Measured: 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.
Measured: 6 months postoperative

Timeline

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

10 May 201723 Feb 2018

First posted13 Apr 2017
Study start10 May 2017
Primary completion23 Feb 2018
Study completion23 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 242 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03111550
Sponsor's protocol ID: EDOF-121-NGPC
Status last verified: Jun 2025
First submitted: 7 Apr 2017
Last updated: 24 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation of the TECNIS Next-Generation Intraocular Lens
ClinicalTrials.gov ID: NCT03111550
Acronym / sponsor ID: EDOF-121-NGPC
Conditions: Cataract
Study type: Interventional
Recruitment status: Completed
Enrolment: 242 participants (actual)
Lead sponsor: Abbott Medical OpticsIndustry (pharma, biotech, devices)
Study start: 10 May 2017 (actual)
Primary completion: 23 Feb 2018 (actual)
Study completion: 23 Feb 2018 (actual)
First posted: 13 Apr 2017 (actual)
Results: Posted 24 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Investigational Lens Device #1	Other	Device: Investigational Intraocular Lens Device #1: TECNIS Model ZHR00Investigational Intraocular Lens Device #1: Tecnis Model ZHR00
Investigational Lens Device #2	Other	Device: Investigational Intraocular Lens Device #2: TECNIS Model ZQR00Investigational Intraocular Lens Device #2: Tecnis Model ZQR00
Control Device	Other	Device: TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00Control TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Investigational Intraocular Lens Device #1: TECNIS Model ZHR00Intraocular lens replaces the natural lens removed during cataract surgery.	Device	Investigational Lens Device #1
Investigational Intraocular Lens Device #2: TECNIS Model ZQR00Intraocular lens replaces the natural lens removed during cataract surgery.	Device	Investigational Lens Device #2
TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00Intraocular lens replaces the natural lens removed during cataract surgery.	Device	Control Device

Primary outcome

Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
Time frame: 1 month postoperative
The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 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)
Time frame: 6 months postoperative
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.
Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)
Time frame: 6 months postoperative
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.

Results and safety

Results posted to the registry on 24 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tecnis ZHR00	77	73
Tecnis ZQR00	73	71
Tecnis ZXR00	79	76

Primary outcome: Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm

Time frame: 1 month postoperative. Mean (Standard Deviation). Unit: LogMAR

Measure	Tecnis ZHR00 n = 76	Tecnis ZQR00 n = 72	Tecnis ZXR00 n = 78
Value	0.136 (0.120)	0.141 (0.149)	0.276 (0.116)

Population analysed: The safety population (SP) of all subjects implanted who have available data will be used for all analysis. For the monocular endpoints, the safety population will consist of first eyes implanted with a study IOL.

Primary outcome: 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)

Time frame: 6 months postoperative. Number. Unit: Percent

Measure	Tecnis ZHR00 n = 73	Tecnis ZQR00 n = 71	Tecnis ZXR00 n = 76
Corneal edema	0.0	0.0	1.3
Cystoid macular edema	0.0	0.0	0.0
Iritis	0.0	0.0	0.0
Raised IOP requiring treatment	0.0	0.0	0.0

Tecnis ZXR00: p = 0.02041, Exact test on binomial distribution

Population analysed: Statistical comparisons to ISO SPE rates are based on first-eye data

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

Time frame: 6 months postoperative. Number. Unit: Percent

Measure	Tecnis ZHR00 n = 77	Tecnis ZQR00 n = 73	Tecnis ZXR00 n = 79
Cystoid Macular Edema	0.0	0.0	1.3
Hypopyon	0.0	0.0	0.0
Endolphthalmitis	0.0	0.0	0.0
Lens dislocated from posterior chamber	0.0	0.0	0.0
Pupillary block	0.0	0.0	0.0
Retinal detachment	0.0	1.4	0.0
Eyes with secondary surgical intervention	1.3	4.1	1.3

Tecnis ZQR00: p = 0.1969, Exact test on binomial distribution
Tecnis ZHR00: p = 0.4655, Exact test of binomial distribution
Tecnis ZQR00: p = 0.0210, Exact test on binomial distribution

Population analysed: Statistical comparisons to ISO SPE rates are based on first-eye data

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tecnis ZHR00	8 of 78 (10.3%)	4 of 78 (5.1%)	2 of 78
ZQR00	7 of 73 (9.6%)	3 of 73 (4.1%)	0 of 73
ZXR00	5 of 79 (6.3%)	3 of 79 (3.8%)	1 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Devi Priya Janakiraman, OD,FAAO study director

Abbott Medical Optics

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 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 24 Aug 2020). 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?

Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm (time frame: 1 month postoperative). The study lists 3 primary outcomes in all. 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 NCT03111550.

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.