Study Stopped
Due to internal reasons study was not performed.
Night Driving Pilot
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
1 other identifier
interventional
N/A
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2009
CompletedFirst Posted
Study publicly available on registry
April 6, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedNovember 28, 2013
November 1, 2013
4 months
April 3, 2009
November 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).
8 months
Study Arms (1)
*AT.Smart 46LC
OTHERThe \*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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy eyes with cataract
- Patient age 50-75 years
- Written Patient Informed Consent
- Assured follow-up examination
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum Augsburg, Klinik für Augenheilkunde
Augsburg, 86156, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arthur J. Mueller, MD
Klinikum Augsburg, Klinik für Augenheilkunde
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2009
First Posted
April 6, 2009
Study Start
June 1, 2009
Primary Completion
October 1, 2009
Study Completion
February 1, 2010
Last Updated
November 28, 2013
Record last verified: 2013-11