CataractPhase 4NCT01278420
AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
A Phase 4 study testing Tecnis MF and ReSTOR in people with Cataract, run by Innovative Medical at 6 sites in United States.
Trial summary
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Tecnis MF and ReSTOR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2010to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or greater
- Bilateral condition (cataracts or Presbyopia) for which phacoemulsification and posterior IOL implantation has been planned for both eyes
- Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
- Clear intraocular media other than cataract
- Normal OCT of the macula
- No evidence of Keratoconus or significant irregular astigmatism on Preoperative topography
- No evidence of Epithelial Basement Membrane Dystrophy on Slit lamp Exam
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Who cannot join
- Use of systemic or ocular medications that may affect vision
- Uncontrolled systemic or ocular disease
- History of ocular trauma
- History of intraocular, extraocular Muscle, or corneal surgery (including laser vision correction)
- Amblyopia or strabismus
- Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
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- Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/25 or worse
- Subjects who may be expected to require retinal laser treatment or other surgical intervention (i.e patients with diabetic retinopathy)
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Contact lens usage within 2 months for PMMA contacts lenses, 2 weeks for gas permeable lenses or 3 days for extended-wear and daily-wear soft contact lenses
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 5 recruiting
- Recruiting
Katzen Eye Care & Laser Center
Boynton Beach, Florida, 33426
Larry Katzen, MD
- Recruiting
Cleveland Eye Clinic
Breckville, Ohio, 44141
Shamik Bafna, MD
- Recruiting
Eye Surgeons of Indiana
Indianapolis, Indiana, 46256
Kevin Waltz, MD
- Recruiting
Jackson Eye, SC
Lake Villa, Illinois, 60046
Mitch Jackson, MD
- Recruiting
The Center for Excellence in Eye Care
Miami, Florida, 33176
William Trattler, MD
- Active, not recruiting
Sansum- Santa Barbara medical foundation Clinic
Santa Barbara, California, 93101
About this study
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.
Read the detailed description
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.
- Conditions
- Cataract
- Being tested
- Tecnis MF, ReSTOR
- Keywords
- Visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis MFDevice
30 subjects will be implanted with the Tecnis MF
ReSTORDevice
30 subjects will be implanted with ReSTOR
| Study group | Role | What they receive |
|---|---|---|
| Tecnis MF | Other | Not described Receives: Device: Tecnis MF |
| ReSTOR | Other | Not described Receives: Device: ReSTOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refraction
Measured: 1 year
Distance Visual Acuities
Measured: 1 year
Near Visual Acuities
Measured: 1 year
Intermediate Acuities
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Trattler, MD, Principal investigator, The Center for Excellence in Eye CareMitch Jackson, MD, Principal investigator, Jackson EyeLarry Katzen, MD, Principal investigator, Katzen Eye Care & Laser CenterKevin Waltz, MD, Principal investigator, Eye Surgeons of IndianaShamik Bafna, MD, Principal investigator, Clevland Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278420
- Sponsor's protocol ID
- TMF vs Restor MF 3D
- Status last verified
- Jun 2012
- First submitted
- 27 Aug 2010
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
- ClinicalTrials.gov ID
- NCT01278420
- Acronym / sponsor ID
- TMF vs Restor MF 3D
- Conditions
- Cataract
- Keywords
- Visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Not posted in the source record
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 study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.
Detailed description
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tecnis MF | Other | Device: Tecnis MF |
| ReSTOR | Other | Device: ReSTOR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 or greater
- Bilateral condition (cataracts or Presbyopia) for which phacoemulsification and posterior IOL implantation has been planned for both eyes
- Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
- Clear intraocular media other than cataract
- Normal OCT of the macula
Key exclusion criteria (10 listed)
- Use of systemic or ocular medications that may affect vision
- Uncontrolled systemic or ocular disease
- History of ocular trauma
- History of intraocular, extraocular Muscle, or corneal surgery (including laser vision correction)
- Amblyopia or strabismus
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 MF30 subjects will be implanted with the Tecnis MF | Device | Tecnis MF |
| ReSTOR30 subjects will be implanted with ReSTOR | Device | ReSTOR |
Primary outcome
Refraction
Time frame: 1 year
Distance Visual Acuities
Time frame: 1 year
Near Visual Acuities
Time frame: 1 year
Intermediate Acuities
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
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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.
William Trattler, MD principal investigator
The Center for Excellence in Eye Care
Mitch Jackson, MD principal investigator
Jackson Eye
Larry Katzen, MD principal investigator
Katzen Eye Care & Laser Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tecnis MF and ReSTOR in people with Cataract, run by Innovative Medical at 6 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 8 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: status not confirmed, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenna Piel (951-653-5566, j.piel@imedsonline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refraction (time frame: 1 year). The study lists 4 primary outcomes in all. 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 14 Jun 2012.