Night Driving Pilot - Full Text View

Sponsored by:	Acri.Tec GmbH
Information provided by:	Acri.Tec GmbH
ClinicalTrials.gov Identifier:	NCT00876278

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 IV

MedlinePlus related topics: Cataract

U.S. FDA Resources

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

Further study details as provided by Acri.Tec GmbH:

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:	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
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.

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

Contacts

Contact: Arthur J. Mueller, MD

+49-821-400 ext 2551

arthur.mueller@klinikum-augsburg.de

Locations

Germany
Klinikum Augsburg, Klinik für Augenheilkunde
Augsburg, Germany, 86156

Sponsors and Collaborators

Acri.Tec GmbH

Investigators

Principal Investigator:

Arthur J. Mueller, MD

Klinikum Augsburg, Klinik für Augenheilkunde

More Information

No publications provided

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

Keywords provided by Acri.Tec GmbH:

Cataract
Intraocular Lens (IOL)
Mesotest II
Evaluation of usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on May 07, 2009