Night Driving Pilot

Carl Zeiss Meditec AG

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Conditions

Cataract

Interventions

*AT.Smart 46LCDEVICE

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

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinikum Augsburg, Klinik für Augenheilkunde

Augsburg, Germany

Outcomes

Primary Outcomes

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

Time frame: 8 months

Data from ClinicalTrials.gov

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