CataractNCT00804726
Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.
A study testing Akreos MI Five-O in people with Cataract, run by Bausch & Lomb Incorporated at 1 site in Germany.
Trial summary
The objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the Bausch \& Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness will be shown through the demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Akreos MI Five-O
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Jul 2010
- Phase
- Interventional
- 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 years and older
- 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.
- Subjects must have clear intraocular media other than cataract.
- Subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
Who cannot join
- Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- Subjects with diagnosis of degenerative visual disorder.
- Subjects who have any inflammation or edema (swelling) of the cornea.
- Subjects with immunodeficiency disorders.
- Subjects who have had previous intraocular surgery in the study eye.
- Subjects with incomplete/damaged zonule, or with conditions associated with increased risk of zonular rupture.
- Subjects with chronic use of systemic steroids or immunosuppressive medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-label, Monocular Feasibility Clinical Evaluation of the Bausch & Lomb Akreos MI Five-O Accommodating Intraocular Lens.
The objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the Bausch \& Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness will be shown through the demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events.
- Conditions
- Cataract
- Being tested
- Akreos MI Five-O
- Keywords
- Cataract extraction, Phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akreos MI Five-ODevice
Small incision cataract surgery with phacoemulsification cataract extraction and Akreos MI Five-O IOL surgical implantation
| Study group | Role | What they receive |
|---|---|---|
| Akreos MI Five-O | Experimental | Accommodating intraocular lens Receives: Device: Akreos MI Five-O |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Uncorrected distance visual acuity Best corrected distance visual acuity Uncorrected near visual acuity Uncorrected intermediate visual acuity Near visual acuity with distance best correction
Measured: 5 visits up to 420 days
Secondary outcomes (1)
Visual acuity
Best corrected near Visual acuity Intermediate visual acuity with distance best correction Subjective near point of accommodation (push down test)
Measured: 5 visits up to 420 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2010
- Study completionJul 2010
Why it stopped: Test lens did not meet near visual efficacy endpoints
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helmut Allmeier, PhD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804726
- Sponsor's protocol ID
- 580
- Status last verified
- Jan 2014
- First submitted
- 8 Dec 2008
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Monocular Feasibility Clinical Evaluation of the Bausch & Lomb Akreos MI Five-O Accommodating Intraocular Lens.
- ClinicalTrials.gov ID
- NCT00804726
- Acronym / sponsor ID
- 580
- Conditions
- Cataract
- Keywords
- Cataract extraction, Phacoemulsification
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Test lens did not meet near visual efficacy endpoints
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Dec 2008 (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 objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the Bausch \& Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness will be shown through the demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Akreos MI Five-O | Experimental | Device: Akreos MI Five-OAccommodating intraocular lens |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have a clinically documented diagnosis of age-related cataract.
- Subjects must have clear intraocular media other than cataract.
- Subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
Key exclusion criteria (7 listed)
- Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- Subjects with diagnosis of degenerative visual disorder.
- Subjects who have any inflammation or edema (swelling) of the cornea.
- Subjects with immunodeficiency disorders.
- Subjects who have had previous intraocular surgery in the study eye.
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 MI Five-OSmall incision cataract surgery with phacoemulsification cataract extraction and Akreos MI Five-O IOL surgical implantation | Device | Akreos MI Five-O |
Primary outcome
Visual acuity
Time frame: 5 visits up to 420 days
Uncorrected distance visual acuity Best corrected distance visual acuity Uncorrected near visual acuity Uncorrected intermediate visual acuity Near visual acuity with distance best correction
1 secondary outcome
Visual acuity
Time frame: 5 visits up to 420 days
Results and safety
The study was stopped early (reason given: Test lens did not meet near visual efficacy endpoints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 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.
Helmut Allmeier, PhD 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 study testing Akreos MI Five-O in people with Cataract, 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 17 Jan 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 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.
Are results available for this study?
The study was stopped early (reason given: Test lens did not meet near visual efficacy endpoints). Results are not available in the source record.
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: 5 visits up to 420 days). 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 17 Jan 2014.