CompletedNCT02203721Updated Jan 11, 2017Results posted

Clinical Investigation of a New Intraocular Lens

An interventional study of TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 and TECNIS Monofocal IOL, Model ZCB00 in Cataract, sponsored by Abbott Medical Optics. Completed at 15 sites in United States. Open to participants aged 22 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-01-11.

Sponsored by Abbott Medical Optics · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 324
Allocation: Randomized
Ages: 22 Years to 99 Years
Sex: All

Study summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.

Conditions studied

Cataract

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Cataract 1,701

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 324 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Abbott Medical Optics is the lead sponsor of 34 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.

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

Who can participate

Ages eligible: 22 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Minimum 22 years of age
Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
Potential for postoperative BCDVA of 20/30 Snellen or better
Corneal astigmatism
Clear intraocular media, other than cataract
Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Signed informed consent and HIPAA authorization
Ability to understand and respond to a questionnaire in English or Spanish

Exclusion criteria

Exclusion Criteria:

Requiring an intraocular lens power outside the available range of +16.0 D to +28.0 D
Pupil abnormalities
Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
Prior corneal refractive or intraocular surgery
Corneal abnormalities
Inability to achieve keratometric stability for contact lens wearers
Subjects with diagnosed degenerative visual disorders that are predicted to cause visual acuity losses to a level of 20/30 Snellen or worse 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, that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject
Inability to focus or fixate for prolonged periods of time
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.
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 30 days prior to preoperative visit in any other clinical trial
Desire for monovision correction

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Outcomes assessor)
Enrollment: 324 participants (actual)

Study arms

Experimental
TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
Active comparator
TECNIS Monofocal IOL, Model ZCB00
Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
Device: TECNIS Monofocal IOL, Model ZCB00

Interventions

DeviceTECNIS Symfony Extended Range of Vision IOL, Model ZXR00
DeviceTECNIS Monofocal IOL, Model ZCB00

What researchers measure

Primary outcomes

Distance Corrected Intermediate Visual Acuity
FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
Time frame: At 6 months
Uncorrected Intermediate Visual Acuity
Uncorrected Intermediate Visual Acuity at 6 months.
Time frame: 6 months

Results

Posted Jan 11, 2017

Participant flow

Beginning August 27, 2014, a total of 324 subjects were enrolled (consented) in the study and 299 of these subjects were implanted with a study lens in at least one operative eye between September 16, 2014, and February 10, 2015, across 15 U.S. clinical sites.

Participant flow — Overall Study
Milestone	TECNIS Intraocular Lens, Model ZXR00	TECNIS Intraocular Lens, Model ZCB00
Started	148	151
Completed	147	148
Not completed	1	3
Withdrew: Lost to follow-up	1	0
Withdrew: Death	0	2
Withdrew: Illness	0	1

Outcome measures

PrimaryDistance Corrected Intermediate Visual Acuity

FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.

Time frame:: At 6 months
Reported as:: Mean · LogMAR

Distance Corrected Intermediate Visual Acuity
LogMAR	TECNIS Intraocular Lens, Model ZXR00	TECNIS Intraocular Lens, Model ZCB00
Distance Corrected Intermediate Visual Acuity	0.105 ± 0.009	0.343 ± 0.013

PrimaryUncorrected Intermediate Visual Acuity

Uncorrected Intermediate Visual Acuity at 6 months.

Time frame:: 6 months
Reported as:: Mean · LogMAR

Uncorrected Intermediate Visual Acuity
LogMAR	TECNIS Intraocular Lens, Model ZXR00	TECNIS Intraocular Lens, Model ZCB00
Uncorrected Intermediate Visual Acuity	0.087 ± 0.009	0.258 ± 0.014

Adverse events

Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
TECNIS Intraocular Lens, Model ZXR00	—	5/148 (3.4%)	0/148 (0%)
TECNIS Intraocular Lens, Model ZCB00	—	11/151 (7.3%)	0/151 (0%)

Most frequent serious events

Most frequent serious events
Event	TECNIS Intraocular Lens, Model ZXR00	TECNIS Intraocular Lens, Model ZCB00
Cystoid Macular EdemaEye disorders	2/148	5/151
Lens FragmentEye disorders	0/148	2/151
Pupillary CaptureEye disorders	1/148	0/151
EndophthalmitisEye disorders	1/148	0/151
HypopyonEye disorders	1/148	0/151
Epiretinal Membrane PeelEye disorders	0/148	1/151
Anterior Ischemic Optic NeuropathyEye disorders	0/148	1/151
Anterior Basement Membrane DistrophyEye disorders	0/148	1/151
InflammationEye disorders	0/148	1/151

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	TECNIS Intraocular Lens, Model ZXR00	TECNIS Intraocular Lens, Model ZCB00	Total
<=18 years	0	0	0
Between 18 and 65 years	85	85	170
>=65 years	63	66	129

Age, Continuous
Age, Continuous(Years)	TECNIS Intraocular Lens, Model ZXR00	TECNIS Intraocular Lens, Model ZCB00	Total
Mean	68.0 ± 7.5	67.9 ± 7.9	67.9 ± 7.7

Gender
Gender(Participants)	TECNIS Intraocular Lens, Model ZXR00	TECNIS Intraocular Lens, Model ZCB00	Total
Female	91	86	177
Male	57	65	122

Region of Enrollment
Region of Enrollment(participants)	TECNIS Intraocular Lens, Model ZXR00	TECNIS Intraocular Lens, Model ZCB00	Total
United States	148	151	299

Study locations

15 sites

Boozman-Hof Regional Eye Clinic
Rogers, Arkansas 72756, United States
Empire Eye & Laser Center
Bakersfield, California 93309, United States
Katzen Eye Care & Laser Center
Boynton Beach, Florida 33426, United States
Cape Coral Eye Center
Cape Coral, Florida 33904, United States
Virdi Eye Clinic & Laser Vision Center
Rock Island, Illinois 61201, United States
Eye Surgeons of Indiana
Indianapolis, Indiana 46256, United States
Jones Eye Clinic
Sioux City, Iowa 51104, United States
Eye Doctors of Washington
Chevy Chase, Maryland 20815, United States
Ophthalmic Consultants of Long Island
Rockville Center, New York 11570, United States
The Eye Center of Central PA
Allenwood, Pennsylvania 17810, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania 16066, United States
Loden Vision Center
Goodlettsville, Tennessee 37072, United States
Whitsett Vision Group
Houston, Texas 77055, United States
Texas Eye and Laser Center
Hurst, Texas 76054, United States
Lehmann Eye Center
Nacogdoches, Texas 75965, United States

References and documents

Publications

Chang DH, Janakiraman DP, Smith PJ, Buteyn A, Domingo J, Jones JJ, Christie WC. Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial. J Cataract Refract Surg. 2022 Mar 1;48(3):288-297. doi: 10.1097/j.jcrs.0000000000000747. PubMed 34269326 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02203721
Lead sponsor: Abbott Medical Optics
Responsible party: Sponsor
First posted: Jul 30, 2014
Start date: Sep 2014
Primary completion: Jun 2015
Completion: Jun 2015
Results posted: Jan 11, 2017
Last update: Jan 11, 2017

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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