CataractNCT02203721
Clinical Investigation of a New Intraocular Lens
A study testing TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 and TECNIS Monofocal IOL, Model ZCB00 in people with Cataract, run by Abbott Medical Optics at 15 sites in United States.
Trial summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL. Read more about this study
- Who is it for?
- Ages 22 to 99 years
- Conditions the study is for
- Cataract
- What is being tested?
- TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 and TECNIS Monofocal IOL, Model ZCB00
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2014to Jun 2015
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
The Eye Center of Central PA
Allenwood, Pennsylvania, 17810
Empire Eye & Laser Center
Bakersfield, California, 93309
Katzen Eye Care & Laser Center
Boynton Beach, Florida, 33426
Cape Coral Eye Center
Cape Coral, Florida, 33904
Eye Doctors of Washington
Chevy Chase, Maryland, 20815
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Loden Vision Center
Goodlettsville, Tennessee, 37072
Whitsett Vision Group
Houston, Texas, 77055
Texas Eye and Laser Center
Hurst, Texas, 76054
Eye Surgeons of Indiana
Indianapolis, Indiana, 46256
Lehmann Eye Center
Nacogdoches, Texas, 75965
Virdi Eye Clinic & Laser Vision Center
Rock Island, Illinois, 61201
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570
Boozman-Hof Regional Eye Clinic
Rogers, Arkansas, 72756
Jones Eye Clinic
Sioux City, Iowa, 51104
About this study
Official title: Clinical Investigation of the Tecnis Symfony Extended Range of Vision IOL, Model ZXR00
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.
- Conditions
- Cataract
- Being tested
- TECNIS Symfony Extended Range of Vision IOL, Model ZXR00, TECNIS Monofocal IOL, Model ZCB00
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECNIS Symfony Extended Range of Vision IOL, Model ZXR00Device
TECNIS Monofocal IOL, Model ZCB00Device
| Study group | Role | What they receive |
|---|---|---|
| TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 | Experimental | Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00 Receives: Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 |
| TECNIS Monofocal IOL, Model ZCB00 | Active comparator | Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00 Receives: Device: TECNIS Monofocal IOL, Model ZCB00 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Corrected Intermediate Visual Acuity
FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
Measured: At 6 months
Uncorrected Intermediate Visual Acuity
Uncorrected Intermediate Visual Acuity at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203721
- Sponsor's protocol ID
- EROV-106-ZXRC
- Status last verified
- Nov 2016
- First submitted
- 24 Jul 2014
- Last updated
- 11 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Tecnis Symfony Extended Range of Vision IOL, Model ZXR00
- ClinicalTrials.gov ID
- NCT02203721
- Acronym / sponsor ID
- EROV-106-ZXRC
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Posted 11 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 | Experimental | Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00 |
| TECNIS Monofocal IOL, Model ZCB00 | Active comparator | Device: TECNIS Monofocal IOL, Model ZCB00Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00 |
Who may qualify
- Ages
- 22 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 | Device | TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 |
| TECNIS Monofocal IOL, Model ZCB00 | Device | TECNIS Monofocal IOL, Model ZCB00 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34269326Chang 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 and TECNIS Monofocal IOL, Model ZCB00 in people with Cataract, run by Abbott Medical Optics at 15 sites in United States.
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 9 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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 11 Jan 2017). 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?
Distance Corrected Intermediate Visual Acuity (time frame: At 6 months). The study lists 2 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 NCT02203721, which also lists 1 linked publication.
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 11 Jan 2017.