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Intermediate Vision in a Driving Simulator Environment: Comparison of the New J&J EYHANCE IOL With a Conventional Monofocal IOL
To compare (low contrast) visual acuity (VA) and contrast sensitivity (CS) - both at intermediate distances under nighttime driving conditions in a driving simulator between patients with bilateral EYHANCE IOLs OR bilateral conventional monofocal IOLs. Visual function testing in the driving simulator will be assessed without AND with (static) glare. Additionally: Assessment of individual response times, scanpath characteristics, evaluation of test retest reliability and self-evaluation of (intermediate) vision and visual impairment related to glare.
To compare (low contrast) visual acuity (VA) and contrast sensitivity (CS) - both at intermediate distances under nighttime driving conditions in a driving simulator between patients with bilateral EYHANCE IOLs OR bilateral conventional monofocal IOLs. Visual function testing in the driving simulator will be assessed without AND with (static) glare. Additionally: Assessment of individual response times, scanpath characteristics, evaluation of test retest reliability and self-evaluation of (intermediate) vision and visual impairment related to glare. Simulator Patients are instructed to drive with a constant speed of 40 km/h on a virtual parcours (straight lane). For testing of either (low contrast) visual acuity or contrast sensitivity, 8-position LANDOLT C's are presented at three locations (within the simulator car, AUDI A4, Ingolstadt/FRG): (i) At the center of the instrument panel (distance 0.xx m) (ii) At the center of the navigation monitor (y.yy m) (iii) At the center of the rear monitor (z.zz m) A high resolution acoustic attention guidance for immediate gaze direction of the patients towards the three above-mentioned visual stimulus locations (i-iii) is mandatory. Patients responses are recorded and response times can be extracted from the recordings. Clinical ophthalmological-optical examinations * Medical/ophthalmological history * (Uncorrected and Best-corrected) visual acuity (RE,LE,BE) with remote and intermediate (66cm) 8 position LANDOLT C's. * LANG I stereotest (near distance) * Ocular alignment \& ocular motility * Efferent \& afferent pupillomotor status * Mesopic contrast sensitivity without/with glare (Optovist, VISTEC Inc./Olching/FRG) * Intraocular straylight perception (Q-Quant, OCULUS Inc, Wetzlar/FRG) * Slit lamp (anterior segment) * Ophthalmoscope (central fundus and fixation) * Primary objectives: log visual acuity (logVA) at preset low contrast level of 1:2.7 (logCS = 0.2) AND log contrast sensitivity (logCS) at a preset visual acuity level of 0.1 = 2/20) * Secondary objectives: test retest reliability (as operationalized by LOA = limits of agreement) AND response time (i.e. time interval between onset of stimulus presentation and final response) AND scanpath characteristics (fixation duration, fixation stability, annotation to regions of interest; saccade amplitude) self-evaluation (questionnaire, using visual analogue scales = VAS) SHAPIRO WILK test (statistical testing for proving/disproving normal distribution) Descriptive statistics (either MEAN, standard deviation, in case of normally distributed data - else, MEDIAN, inter-quartile range (IQR). Assessment of test/retest reliability: BLAND ALTMAN plots, limits of agreement (LOA) Between-group comparison: t-test (unpaired samples), in case of normally distributed data - else, WILCOXON signed-rank test
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Applied Sciences, Study Course Ophthalmic Optics
Aalen, Baden-Wurttemberg, Germany
Start Date
January 7, 2020
Primary Completion Date
March 15, 2020
Completion Date
March 15, 2020
Last Updated
March 31, 2020
11
ACTUAL participants
Posterior chamber intraocular lens (IOL)
OTHER
Lead Sponsor
Aalen University
Collaborators
NCT04692012
NCT06064916
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06045299