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Night Driving Pilot

This study has been withdrawn prior to enrollment.
(Due to internal reasons study was not performed.)
Sponsor:
Information provided by:
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
NCT00876278
First received: April 3, 2009
Last updated: July 23, 2009
Last verified: July 2009
History of Changes
  Purpose

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
Cataract
 Device: *AT.Smart 46LC
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Carl Zeiss Meditec AG:

Primary Outcome Measures:
  • Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus). [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
*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 *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 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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy eyes with cataract
  • Patient age 50-75 years
  • Written Patient Informed Consent
  • Assured follow-up examination

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876278

Locations
Germany
Klinikum Augsburg, Klinik für Augenheilkunde
Augsburg, Germany, 86156
Sponsors and Collaborators
Carl Zeiss Meditec AG
Investigators
Principal Investigator: Arthur J. Mueller, MD Klinikum Augsburg, Klinik für Augenheilkunde
  More Information

No publications provided

Responsible Party: Andreas Langer, Dipl.-Biol., *Acri.Tec GmbH, A Carl Zeiss Meditec Company
ClinicalTrials.gov Identifier: NCT00876278     History of Changes
Other Study ID Numbers: 46LC HEN 401-08
Study First Received: April 3, 2009
Last Updated: July 23, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Carl Zeiss Meditec AG:
Cataract
Intraocular Lens (IOL)
Mesotest II
Evaluation of usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013