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

Pseudophakia Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Driving
• Lenses, Intraocular
• Near Vision
• Pseudophakia

• NCT number: NCT04059289
• Study type: Observational
• Source: Aalen University
• Status: Completed
• Start date: January 7, 2020
• Completion date: March 15, 2020