CataractPhase 4NCT00838045
Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
A Phase 4 study testing The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL in people with Cataract and Aphakia, run by Bausch & Lomb Incorporated at 1 site in Germany.
Trial summary
This study is to evaluate the safety and effectiveness of the Bausch \& Lomb Akreos TL (thin lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- What is being tested?
- The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Sep 2008
- 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 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
- Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
- Subjects must require a lens power from 15 to 30 diopters.
- Subjects must have a visual potential of 20/40 or better in the study eye.
Who cannot join
- Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- Subjects with any inflammation or edema (swelling) of the cornea.
- Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
- Subjects with previous retinal detachment.
- Subjects with diabetic retinopathy (proliferative or non-proliferative).
- Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
- Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
- Subjects who have already received an Akreos TL IOL in the fellow eye.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens
This study is to evaluate the safety and effectiveness of the Bausch \& Lomb Akreos TL (thin lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.
- Being tested
- The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL
- Medical subject headings
- Cataract, Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOLDevice
Surgery to implant the Bausch \& Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Akreos TL intraocular lens | Experimental | Bausch \& Lomb Akreos TL intraocular lens Receives: Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bast Corrected Visual Acuity
best-corrected visual acuity (BCVA)
Measured: 24 months
Secondary outcomes (2)
Uncorrected Visual Acuity
Measured: 24 months
Manifest Refraction
mean manifest refraction
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startSep 2006
- Primary completionApr 2008
- Study completionSep 2008
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Kohnen, Principal investigator, Klinikum der J.W. Goethe-Universität
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838045
- Sponsor's protocol ID
- 451
- Status last verified
- Dec 2011
- First submitted
- 5 Feb 2009
- Last updated
- 9 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens
- ClinicalTrials.gov ID
- NCT00838045
- Acronym / sponsor ID
- 451
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Feb 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.
This study is to evaluate the safety and effectiveness of the Bausch \& Lomb Akreos TL (thin lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Akreos TL intraocular lens | Experimental | Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOLBausch \& Lomb Akreos TL intraocular lens |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
- Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
- Subjects must require a lens power from 15 to 30 diopters.
- Subjects must have a visual potential of 20/40 or better in the study eye.
Key exclusion criteria (8 listed)
- Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- Subjects with any inflammation or edema (swelling) of the cornea.
- Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
- Subjects with previous retinal detachment.
- Subjects with diabetic retinopathy (proliferative or non-proliferative).
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 |
|---|---|---|
| The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOLSurgery to implant the Bausch \& Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery. | Device | Akreos TL intraocular lens |
Primary outcome
Bast Corrected Visual Acuity
Time frame: 24 months
best-corrected visual acuity (BCVA)
2 secondary outcomes
Uncorrected Visual Acuity
Time frame: 24 months
Manifest Refraction
Time frame: 24 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 9 Dec 2011.
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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.
Thomas Kohnen principal investigator
Klinikum der J.W. Goethe-Universität
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 The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL in people with Cataract and Aphakia, run by Bausch & Lomb Incorporated at 1 site in Germany.
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 8 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 9 Dec 2011. 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 Germany. 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?
Bast Corrected Visual Acuity (time frame: 24 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 9 Dec 2011.