NCT00876278WithdrawnPhase 4
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
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Carl Zeiss Meditec AG
- Locations
- 2
- Primary Endpoint
- Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).
Time Frame: 8 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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