CataractPhase 4NCT00876278
Night Driving Pilot
A Phase 4 study testing *AT.Smart 46LC in people with Cataract, run by Carl Zeiss Meditec AG at 1 site in Germany.
Trial summary
Pilot study to evaluate usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients implanted with aspheric monofocal posterior chamber IOL *AT.Smart 46LC. Target Criterion: Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus). Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Cataract
- What is being tested?
- *AT.Smart 46LC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Feb 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy eyes with cataract
- Patient age 50-75 years
- Written Patient Informed Consent
- Assured follow-up examination
Who cannot join
- Any kind of macula degeneration and impairment of retina (clinical diagnosis)
- Amblyopia
- Intraoperative complications; damaged posterior bag; intraocular haemorrhage
- Astigmatism > 1.5 D (objective, preoperative)
- Pregnancy or lactation period for female patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Study to Evaluate Usability of Mesotest II for Assessment of Night Driving Capacity of Pseudophakic Patients Implanted With Monofocal IOL *AT.Smart 46LC
Pilot study to evaluate usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients implanted with aspheric monofocal posterior chamber IOL *AT.Smart 46LC.
Target Criterion:
Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).
- Conditions
- Cataract
- Being tested
- *AT.Smart 46LC
- Keywords
- Cataract, Intraocular Lens (IOL), Mesotest II, Evaluation of usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
*AT.Smart 46LCDevice
Primary implantation of *AT.Smart 46 LC into the eye's capsular bag for the visual correction of aphakia in persons in whom the cataractous lens has been removed by phacoemulsification extracapsular cataract extraction. The IOL is intended to be placed only in an intact capsular bag. When implanted, the *AT.Smart 46LC replaces the natural lens of the eye and functions as a refracting medium in the correction of aphakia.
| Study group | Role | What they receive |
|---|---|---|
| *AT.Smart 46LC | Other | The *AT.Smart 46LC is indicated for primary implantation for the visual correction of aphakia in persons in whom the cataractous lens has been removed by phacoemulsification extracapsular cataract extraction. The IOL is intended to be placed only in an intact capsular bag. When implanted, the *AT.Smart 46LC replaces the natural lens of the eye and functions as a refracting medium in the correction of aphakia. Receives: Device: *AT.Smart 46LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2009 (estimated)
- Study completionFeb 2010 (estimated)
Why it stopped: Due to internal reasons study was not performed.
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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur J. Mueller, MD, Principal investigator, Klinikum Augsburg, Klinik für Augenheilkunde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876278
- Sponsor's protocol ID
- 46LC HEN 401-08
- Status last verified
- Nov 2013
- First submitted
- 3 Apr 2009
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study to Evaluate Usability of Mesotest II for Assessment of Night Driving Capacity of Pseudophakic Patients Implanted With Monofocal IOL *AT.Smart 46LC
- ClinicalTrials.gov ID
- NCT00876278
- Acronym / sponsor ID
- 46LC HEN 401-08
- Conditions
- Cataract
- Keywords
- Cataract, Intraocular Lens (IOL), Mesotest II, Evaluation of usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to internal reasons study was not performed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 6 Apr 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.
Pilot study to evaluate usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients implanted with aspheric monofocal posterior chamber IOL *AT.Smart 46LC.
Target Criterion:
Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| *AT.Smart 46LC | Other | Device: *AT.Smart 46LCThe *AT.Smart 46LC is indicated for primary implantation for the visual correction of aphakia in persons in whom the cataractous lens has been removed by phacoemulsification extracapsular cataract extraction. The IOL is intended to be placed only in an intact capsular bag. When implanted, the *AT.Smart 46LC replaces the natural lens of the eye and functions as a refracting medium in the correction of aphakia. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy eyes with cataract
- Patient age 50-75 years
- Written Patient Informed Consent
- Assured follow-up examination
Key exclusion criteria (5 listed)
- Any kind of macula degeneration and impairment of retina (clinical diagnosis)
- Amblyopia
- Intraoperative complications; damaged posterior bag; intraocular haemorrhage
- Astigmatism > 1.5 D (objective, preoperative)
- Pregnancy or lactation period for female patients
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 |
|---|---|---|
| *AT.Smart 46LCPrimary implantation of *AT.Smart 46 LC into the eye's capsular bag for the visual correction of aphakia in persons in whom the cataractous lens has been removed by phacoemulsification extracapsular cataract extraction. The IOL is intended to be placed only in an intact capsular bag. When implanted, the *AT.Smart 46LC replaces the natural lens of the eye and functions as a refracting medium in the correction of aphakia. | Device | *AT.Smart 46LC |
Primary outcome
Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).
Time frame: 8 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 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.
Arthur J. Mueller, MD principal investigator
Klinikum Augsburg, Klinik für Augenheilkunde
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 *AT.Smart 46LC in people with Cataract, run by Carl Zeiss Meditec AG 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 5 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: withdrawn, as of the sponsor's last update on 28 Nov 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus). (time frame: 8 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 28 Nov 2013.