Trials / Completed

CompletedNCT04059289

Intermediate Vision in a Driving Simulator Environment: Comparison of the J&J EYHANCE With a Conventional Monofoc. IOL

Intermediate Vision in a Driving Simulator Environment: Comparison of the New J&J EYHANCE IOL With a Conventional Monofocal IOL

Status: Completed
Phase: —
Study type: Observational
Enrollment: 11 (actual)

Sponsor: Aalen University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: —

Summary

Detailed description

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

Conditions

Interventions

Type	Name	Description
OTHER	Posterior chamber intraocular lens (IOL)	This is NOT an interventional study; the intervention (surgical procedure) has been performed PRIOR to the inclusion in this study

Timeline

Start date: 2020-01-07
Primary completion: 2020-03-15
Completion: 2020-03-15
First posted: 2019-08-16
Last updated: 2020-03-31

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT04059289. Inclusion in this directory is not an endorsement.