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Sponsored by: |
Acri.Tec GmbH |
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Information provided by: | Acri.Tec GmbH |
ClinicalTrials.gov Identifier: | NCT00876278 |
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).
Condition | Intervention | Phase |
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Cataract |
Device: *AT.Smart 46LC |
Phase IV |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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*AT.Smart 46LC
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
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Device: *AT.Smart 46LC
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.
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Ages Eligible for Study: | 50 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Arthur J. Mueller, MD | +49-821-400 ext 2551 | arthur.mueller@klinikum-augsburg.de |
Germany | |
Klinikum Augsburg, Klinik für Augenheilkunde | |
Augsburg, Germany, 86156 |
Principal Investigator: | Arthur J. Mueller, MD | Klinikum Augsburg, Klinik für Augenheilkunde |
Responsible Party: | *Acri.Tec GmbH, A Carl Zeiss Meditec Company ( Andreas Langer, Dipl.-Biol. ) |
Study ID Numbers: | 46LC HEN 401-08 |
Study First Received: | April 3, 2009 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00876278 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Cataract Intraocular Lens (IOL) Mesotest II Evaluation of usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients |
Eye Diseases Cataract Lens Diseases |
Eye Diseases Cataract Lens Diseases |