CataractNCT02566083
Post-Approval Study of the Tecnis® Toric IOL
A study testing non-toric intraocular lens and toric intraocular lens in people with Cataract, run by Abbott Medical Optics at 44 sites in United States.
Trial summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- non-toric intraocular lens and toric intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 44 sitesUnited States
- Study dates
- 21 Oct 2015to 23 May 2019
- 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
- Minimum 22 years of age
- Bilateral cataracts
- Preoperative keratometric cylinder in both eyes
- Most appropriate toric IOL model choice (ZCT300 or ZCT400)
- Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be:
- ≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL
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- Clear intraocular media other than cataract in each eye
- Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
- Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire
- Signed informed consent and HIPAA authorization
Who cannot join
- Irregular corneal astigmatism
- Any corneal pathology/abnormality other than regular corneal astigmatism
- Previous corneal surgery
- Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes
- Any pupil abnormalities
- Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
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- Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study
- Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study
- Planned monovision correction
- 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
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Eye Associates of New Mexico
Albuquerque, New Mexico, 87109
The Eye Center of Central PA
Allenwood, Pennsylvania, 17810
Chesapeake Eye Care and Laser Center
Annapolis, Maryland, 21401
Empire Eye & Laser Center
Bakersfield, California, 93309
Oakland Ophthalmic Surgery, P.C.
Birmingham, Michigan, 48009
Solomon Eye Associates
Bowie, Maryland, 20716
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, 33426
Katzen Eye Care & Laser Center
Boynton Beach, Florida, 33426
The Eye Associates
Bradenton, Florida, 34209
Cape Coral Eye Center
Cape Coral, Florida, 336904
Ludwick Eye Center
Chambersburg, Pennsylvania, 17201
Arizona Eye Cente
Chandler, Arizona, 85225
TLC Eye Care and Laser Centers
Chelsea, Michigan, 48118
Kindermann Eye Associates
Cherry Hill, New Jersey, 08002
Eye Doctors of Washington
Chevy Chase, Maryland, 20815
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Eye Center South
Dothan, Alabama, 36301
Fine, Hoffman & Sims
Eugene, Oregon, 97401
Loden Vision Centers
Goodlettsville, Tennessee, 37072
Houston Eye Associates
Houston, Texas, 77025
Whitsett Vision Group
Houston, Texas, 77055
Atlantis Eye Care
Huntington Beach, California, 92647
Levenson Eye Associates, Inc.
Jacksonville, Florida, 32204
Scripps Clinic Medical Group
La Jolla, California, 92037
Clarus Eye Centre
Lacey, Washington, 98503
Carolina Cataract & Laser Center
Ladson, South Carolina, 29456
Southern California Eye Physicians & Associates
Long Beach, California, 90805
Senior Health Services
Louisville, Kentucky, 40220
Pamel Vision & Laser Group
New York, New York, 10065
Feinerman Vision Center
Newport Beach, California, 92663
Coastal Vision
Orange, California, 92868
California Eye Medical Specialists
Pasadena, California, 91107
Matossian Eye Associates
Pennington, New Jersey, 08534
Virdi Eye Clinic & Laser Vision Center
Rock Island, Illinois, 61201
Boozman-Hof Regional Eye Clinic
Rogers, Arkansas, 72757
Focal Point Vision
San Antonio, Texas, 78229
San Antonio Eye Specialists
San Antonio, Texas, 78248
Vance Thompson Vision
Sioux Falls, South Dakota, 57105
Mercy Clinic Eye Specialist
Springfield, Missouri, 65804
Ophthalmology Associates
St Louis, Missouri, 63131
Ophthalmology Consultants
St Louis, Missouri, 63131
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
Fishkind, Bakewell & Maltzman Eye Care & Surgery Cente
Tucson, Arizona, 85704
About this study
Official title: Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference
- Conditions
- Cataract
- Being tested
- non-toric intraocular lens, toric intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-toric intraocular lensDevice
TECNIS One-piece Monofocal Model ZCB00
toric intraocular lensDevice
TECNIS One-piece Toric Models ZCT300 or ZCT400
| Study group | Role | What they receive |
|---|---|---|
| non-toric intraocular lens | Active comparator | non-toric approved intraocular lens Receives: Device: non-toric intraocular lens |
| toric intraocular lens | Active comparator | approved toric intraocular lens Receives: Device: toric intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Severe Visual Distortions
The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.
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 posted1 Oct 2015 (estimated)
- Study start21 Oct 2015
- Primary completion11 Dec 2018
- Study completion23 May 2019
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Devi Priya Janakiraman, OD, FAAO, Study director, Johnson & Johnson Surgical Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566083
- Sponsor's protocol ID
- TIOL-202-TPAS
- Status last verified
- Jan 2020
- First submitted
- 30 Sep 2015
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400
- ClinicalTrials.gov ID
- NCT02566083
- Acronym / sponsor ID
- TIOL-202-TPAS
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2015 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Posted 18 Jan 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 prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-toric intraocular lens | Active comparator | Device: non-toric intraocular lensnon-toric approved intraocular lens |
| toric intraocular lens | Active comparator | Device: toric intraocular lensapproved toric intraocular lens |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Minimum 22 years of age
- Bilateral cataracts
- Preoperative keratometric cylinder in both eyes
- Most appropriate toric IOL model choice (ZCT300 or ZCT400)
- Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be:
Key exclusion criteria (10 listed)
- Irregular corneal astigmatism
- Any corneal pathology/abnormality other than regular corneal astigmatism
- Previous corneal surgery
- Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes
- Any pupil 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 |
|---|---|---|
| non-toric intraocular lensTECNIS One-piece Monofocal Model ZCB00 | Device | non-toric intraocular lens |
| toric intraocular lensTECNIS One-piece Toric Models ZCT300 or ZCT400 | Device | toric intraocular lens |
Primary outcome
Rate of Severe Visual Distortions
Time frame: 6 months
The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- 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
Johnson & Johnson Surgical Vision
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-toric intraocular lens and toric intraocular lens in people with Cataract, run by Abbott Medical Optics at 44 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 10 inclusion and 10 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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 18 Jan 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?
Rate of Severe Visual Distortions (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2020.