CataractPhase 4NCT00825513
Safety and Effectiveness of the Akreos Toric Intraocular Lens.
A Phase 4 study testing Akreos Toric IOL and Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO) in people with Cataract and Astigmatism, run by Bausch & Lomb Incorporated at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Astigmatism
- What is being tested?
- Akreos Toric IOL and Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2009to Sep 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
- Subjects must be willing and able to provide written consent on the EC approved Informed Consent form.
- Subjects must require a lens power from 15 to 30 diopters.
Who cannot join
- Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- Subjects with corneal pathology potentially affecting topography.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital
Umeå, SE-901 85
About this study
Official title: Monocular Study to Evaluate the Safety and Effectiveness of the Akreos™ Toric IOL When Used to Correct Primary Aphakia With the Reduction of Astigmatism
The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.
- Conditions
- Cataract, Astigmatism
- Being tested
- Akreos Toric IOL, Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akreos Toric IOLDevice
Lens implant following cataract surgery
Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)Device
Lens implant following cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Akreos Toric | Experimental | Akreos Toric Intraocular Lens Receives: Device: Akreos Toric IOL |
| Akreos Advanced | Active comparator | Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO) Receives: Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of cylinder, Lens axis misalignment as determined by a photographic method.
Measured: 32 months
Secondary outcomes (1)
Lens misalignment as determined by postoperative manifest refraction and vector analysis.
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2012
- Study completionSep 2012
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriele Brenger, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825513
- Sponsor's protocol ID
- 566
- Status last verified
- Mar 2013
- First submitted
- 16 Jan 2009
- Last updated
- 25 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocular Study to Evaluate the Safety and Effectiveness of the Akreos™ Toric IOL When Used to Correct Primary Aphakia With the Reduction of Astigmatism
- ClinicalTrials.gov ID
- NCT00825513
- Acronym / sponsor ID
- 566
- Conditions
- Cataract, Astigmatism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Jan 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.
The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Akreos Toric | Experimental | Device: Akreos Toric IOLAkreos Toric Intraocular Lens |
| Akreos Advanced | Active comparator | Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must be willing and able to provide written consent on the EC approved Informed Consent form.
- Subjects must require a lens power from 15 to 30 diopters.
Key exclusion criteria (2 listed)
- Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- Subjects with corneal pathology potentially affecting topography.
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 |
|---|---|---|
| Akreos Toric IOLLens implant following cataract surgery | Device | Akreos Toric |
| Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)Lens implant following cataract surgery | Device | Akreos Advanced |
Primary outcome
Reduction of cylinder, Lens axis misalignment as determined by a photographic method.
Time frame: 32 months
1 secondary outcome
Lens misalignment as determined by postoperative manifest refraction and vector analysis.
Time frame: 32 months
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 25 Mar 2013.
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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.
Gabriele Brenger study director
Bausch & Lomb Incorporated
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 Akreos Toric IOL and Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO) in people with Cataract and Astigmatism, run by Bausch & Lomb Incorporated at 1 site in Sweden.
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 2 inclusion and 2 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 25 Mar 2013. 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 Sweden. 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?
Reduction of cylinder, Lens axis misalignment as determined by a photographic method. (time frame: 32 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 25 Mar 2013.