CataractsPhase 4NCT00999492
Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront
A Phase 4 study testing Tecnis® Multifocal (TMF) in people with Cataracts, run by Mark Packer, MD, FACS at 1 site in United States.
Trial summary
Given the availability of aspheric diffractive IOLs with varying negative spherical aberration it may be feasible, by selecting the best fit IOL, to minimize aberrations and thereby maximize visual performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataracts
- What is being tested?
- Tecnis® Multifocal (TMF)
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Scheduled to undergo bilateral cataract or refractive lens surgery
- Visual potential of 20/30 or better in each eye after lens removal and IOL implantation
- Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
- Preoperative regular corneal astigmatism of 2.5 D or less
- Clear intraocular media other than cataract
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Who cannot join
- Ocular disease other than cataract which could potentially limit uncorrected visual acuity or visual performance.
- Astigmatism not correctable by limbal relaxing incisions (greater than 2.5 D)
- Use of systemic or ocular medications that may affect visual outcomes
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- Uncontrolled systemic or ocular disease
- History of ocular trauma or prior ocular surgery
Show all 14Show fewer
- 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.)
- Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30
- Subjects who may be expected to require retinal laser treatment or other surgical intervention
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)
- Contact lens usage within 6 months for PMMA lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft lenses
- Requiring an intraocular lens power <15.0 or >26.0 diopters
Trial locations and contacts
1 site in 1 country.
United States1 site
Drs. Fine, Hoffman and Packer, LLC
Eugene, Oregon, 97401
About this study
Official title: Selection of Aspheric Diffractive Multifocal IOLS Based on Corneal Wavefront
Given the availability of aspheric diffractive IOLs with varying negative spherical aberration it may be feasible, by selecting the best fit IOL, to minimize aberrations and thereby maximize visual performance.
- Conditions
- Cataracts
- Being tested
- Tecnis® Multifocal (TMF)
- Keywords
- Tecnis Multifocal, Patients scheduled for cataract or lens replacement surgery with implantation of multifocal intraocular lenses
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis® Multifocal (TMF)Device
Aspheric, diffractive multifocal intraocular lenses
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of spectacle wear
Measured: 3 months postoperatively
Secondary outcomes (1)
Frequency and degree of visual symptoms
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Packer, MD, FACS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark Packer, MD, FACS, Drs. Fine, Hoffman and Packer, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999492
- Sponsor's protocol ID
- TMF-09-001
- Status last verified
- Feb 2014
- First submitted
- 19 Oct 2009
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selection of Aspheric Diffractive Multifocal IOLS Based on Corneal Wavefront
- ClinicalTrials.gov ID
- NCT00999492
- Acronym / sponsor ID
- TMF-09-001
- Conditions
- Cataracts
- Keywords
- Tecnis Multifocal, Patients scheduled for cataract or lens replacement surgery with implantation of multifocal intraocular lenses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mark Packer, MD, FACSUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 21 Oct 2009 (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.
Given the availability of aspheric diffractive IOLs with varying negative spherical aberration it may be feasible, by selecting the best fit IOL, to minimize aberrations and thereby maximize visual performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Scheduled to undergo bilateral cataract or refractive lens surgery
- Visual potential of 20/30 or better in each eye after lens removal and IOL implantation
- Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
- Preoperative regular corneal astigmatism of 2.5 D or less
Key exclusion criteria (14 listed)
- Ocular disease other than cataract which could potentially limit uncorrected visual acuity or visual performance.
- Astigmatism not correctable by limbal relaxing incisions (greater than 2.5 D)
- Use of systemic or ocular medications that may affect visual outcomes
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- Uncontrolled systemic or ocular disease
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® Multifocal (TMF)Aspheric, diffractive multifocal intraocular lenses | Device | – |
Primary outcome
Frequency of spectacle wear
Time frame: 3 months postoperatively
1 secondary outcome
Frequency and degree of visual symptoms
Time frame: 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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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.
1 site 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® Multifocal (TMF) in people with Cataracts, run by Mark Packer, MD, FACS at 1 site 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 7 inclusion and 14 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 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of spectacle wear (time frame: 3 months postoperatively). 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 28 Feb 2014.