CataractsPhase 4NCT01279031
Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial
A Phase 4 study testing Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound and Alcon Infiniti wiht the OZIL Torsional Handpiece in people with Cataracts and Astigmatism, run by Innovative Medical at 1 site in United States.
Trial summary
The purpose of this study is to look at the outcomes of your vision after your cataract surgery based on two different types of equipment that will be used during your surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataracts, Astigmatism
- What is being tested?
- Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound and Alcon Infiniti wiht the OZIL Torsional Handpiece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jan 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at least 21 scheduled to undergo bilateral phacoemulsification with implantation of multifocal IOLs.
- Both eyes must have similar degrees of cataract and astigmatism (topographic cylinder difference of <2.00D as well as similar globe axial length as measured by the IOL Master of <0.5mm).
- Visual potential of UCVA 20/25/ or better.
- Clear intraocular media other than cataract.
Who cannot join
- Clinically relevant differences between eyes in ocular disease or pathology.
- Presence of glaucoma, macular disease, or foveal disease to an asymmetrical degree.
- Asymmetrical use of ocular medications.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to look at the outcomes of your vision after your cataract surgery based on two different types of equipment that will be used during your surgery.
- Conditions
- Cataracts, Astigmatism
- Being tested
- Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound, Alcon Infiniti wiht the OZIL Torsional Handpiece
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott WHITESTAR Signature System with Ellips Transversal UltrasoundDevice
Comparison of vision after cataract surgery based on two different types of equipment.
Alcon Infiniti wiht the OZIL Torsional HandpieceDevice
Comparision of vision after cataract surgery based on two different types of equipment.
| Study group | Role | What they receive |
|---|---|---|
| Abbott WHITESTAR Signature System | Experimental | Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound Receives: Device: Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound |
| Alcon Infiniti | Experimental | Alcon Infiniti with the OZIL Torsional Handpiece Receives: Device: Alcon Infiniti wiht the OZIL Torsional Handpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
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 posted19 Jan 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionJan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279031
- Sponsor's protocol ID
- Abbott2010-Whitestar
- Status last verified
- Jan 2012
- First submitted
- 14 Jan 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial
- ClinicalTrials.gov ID
- NCT01279031
- Acronym / sponsor ID
- Abbott2010-Whitestar
- Conditions
- Cataracts, Astigmatism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 19 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 look at the outcomes of your vision after your cataract surgery based on two different types of equipment that will be used during your surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abbott WHITESTAR Signature System | Experimental | Device: Abbott WHITESTAR Signature System with Ellips Transversal UltrasoundAbbott WHITESTAR Signature System with Ellips Transversal Ultrasound |
| Alcon Infiniti | Experimental | Device: Alcon Infiniti wiht the OZIL Torsional HandpieceAlcon Infiniti with the OZIL Torsional Handpiece |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients at least 21 scheduled to undergo bilateral phacoemulsification with implantation of multifocal IOLs.
- Both eyes must have similar degrees of cataract and astigmatism (topographic cylinder difference of <2.00D as well as similar globe axial length as measured by the IOL Master of <0.5mm).
- Visual potential of UCVA 20/25/ or better.
- Clear intraocular media other than cataract.
Key exclusion criteria (3 listed)
- Clinically relevant differences between eyes in ocular disease or pathology.
- Presence of glaucoma, macular disease, or foveal disease to an asymmetrical degree.
- Asymmetrical use of ocular medications.
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 |
|---|---|---|
| Abbott WHITESTAR Signature System with Ellips Transversal UltrasoundComparison of vision after cataract surgery based on two different types of equipment. | Device | Abbott WHITESTAR Signature System |
| Alcon Infiniti wiht the OZIL Torsional HandpieceComparision of vision after cataract surgery based on two different types of equipment. | Device | Alcon Infiniti |
Primary outcome
Visual acuity
Time frame: 1 year
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 18 Jan 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.
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 Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound and Alcon Infiniti wiht the OZIL Torsional Handpiece in people with Cataracts and Astigmatism, run by Innovative Medical 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 4 inclusion and 3 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 2012. 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?
Visual acuity (time frame: 1 year). 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 2012.