Clinical Investigation of a New Intraocular Lens
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02203721 |
Recruitment Status :
Completed
First Posted : July 30, 2014
Results First Posted : January 11, 2017
Last Update Posted : January 11, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cataract | Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 Device: TECNIS Monofocal IOL, Model ZCB00 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 324 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Clinical Investigation of the Tecnis Symfony Extended Range of Vision IOL, Model ZXR00 |
Study Start Date : | September 2014 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |
Arm | Intervention/treatment |
---|---|
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 |
- Distance Corrected Intermediate Visual Acuity [ Time Frame: At 6 months ]FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
- Uncorrected Intermediate Visual Acuity [ Time Frame: 6 months ]Uncorrected Intermediate Visual Acuity at 6 months.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 22 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203721
United States, Arkansas | |
Boozman-Hof Regional Eye Clinic | |
Rogers, Arkansas, United States, 72756 | |
United States, California | |
Empire Eye & Laser Center | |
Bakersfield, California, United States, 93309 | |
United States, Florida | |
Katzen Eye Care & Laser Center | |
Boynton Beach, Florida, United States, 33426 | |
Cape Coral Eye Center | |
Cape Coral, Florida, United States, 33904 | |
United States, Illinois | |
Virdi Eye Clinic & Laser Vision Center | |
Rock Island, Illinois, United States, 61201 | |
United States, Indiana | |
Eye Surgeons of Indiana | |
Indianapolis, Indiana, United States, 46256 | |
United States, Iowa | |
Jones Eye Clinic | |
Sioux City, Iowa, United States, 51104 | |
United States, Maryland | |
Eye Doctors of Washington | |
Chevy Chase, Maryland, United States, 20815 | |
United States, New York | |
Ophthalmic Consultants of Long Island | |
Rockville Center, New York, United States, 11570 | |
United States, Pennsylvania | |
The Eye Center of Central PA | |
Allenwood, Pennsylvania, United States, 17810 | |
Scott & Christie and Associates, PC | |
Cranberry Township, Pennsylvania, United States, 16066 | |
United States, Tennessee | |
Loden Vision Center | |
Goodlettsville, Tennessee, United States, 37072 | |
United States, Texas | |
Whitsett Vision Group | |
Houston, Texas, United States, 77055 | |
Texas Eye and Laser Center | |
Hurst, Texas, United States, 76054 | |
Lehmann Eye Center | |
Nacogdoches, Texas, United States, 75965 |
Responsible Party: | Abbott Medical Optics |
ClinicalTrials.gov Identifier: | NCT02203721 |
Other Study ID Numbers: |
EROV-106-ZXRC |
First Posted: | July 30, 2014 Key Record Dates |
Results First Posted: | January 11, 2017 |
Last Update Posted: | January 11, 2017 |
Last Verified: | November 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Cataract Lens Diseases Eye Diseases |