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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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00876278
Enrollment
0
Registered
2009-04-06
Start date
2009-06-30
Completion date
2010-02-28
Last updated
2013-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

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

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).

Interventions

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.

Sponsors

Carl Zeiss Meditec AG
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).8 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026