Night Driving Pilot

Cataract Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00876278
• Other study ID #: 46LC HEN 401-08
• Status: Withdrawn
• Phase: Phase 4
• First received: April 3, 2009
• Last updated: November 27, 2013
• Start date: June 2009
• Est. completion date: February 2010

Study information

• Verified date: November 2013
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cataract

Intervention

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.

Locations

Country	Name	City	State
Germany	Klinikum Augsburg, Klinik für Augenheilkunde	Augsburg

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).		8 months	No