Night Driving Pilot

Carl Zeiss Meditec

Status and phase: Withdrawn; Phase 4

Conditions: Cataract

Treatments: Device: *AT.Smart 46LC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00876278

46LC HEN 401-08

Details and patient eligibility

About

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).

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

*AT.Smart 46LC

Other group

Description:

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.

Treatment:

Device: *AT.Smart 46LC