Night Driving Pilot

• Sponsor: Carl Zeiss Meditec AG (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT00876278
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 0

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: *AT.Smart 46LC	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jun 1, 2009
• Anticipated Primary Completion Date: Oct 1, 2009
• Anticipated Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Other: *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.

Outcome Measures

Primary Outcome Measures

1. Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus). [8 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carl Zeiss Meditec AG
• ClinicalTrials.gov Identifier: NCT00876278
• Other Study ID Numbers: 46LC HEN 401-08
• First Posted: Apr 6, 2009
• Last Update Posted: Nov 28, 2013
• Last Verified: Nov 1, 2013

• 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

Study Results

No Results Posted as of Nov 28, 2013