An observational study in Lenses, Intraocular, Pseudophakia and Near Vision, sponsored by Aalen University. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-31.
Sponsored by Aalen University · Observational
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
Ophthalmoscope (central fundus and fixation)
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
Subjects of male or femal gender above the age of 18 years at least two months post surgery after bilateral uneventful IOL surgery (bilateral implantation of either EYHANCE IOL OR monofocal IOL)
Exclusion Criteria:
Tecnis EYHANCE IOL (Johnson \& Johnson, New Brunswick/USA)
Other: Posterior chamber intraocular lens (IOL)
Clareon IOL (Alcon Pharma. Freiburg/FRG)
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
Also known as: Tecnis EYHANCE IOL (Johnson & Johnson, New Brunswick/USA), Clareon IOL (Alcon Pharma. Freiburg/FRG)
logVA
logarithm of visual acuity at preset low contrast level of 1:2.7 (logCS = 0.2)
Time frame: at least two months after uneventful intraocular lens implantation
logCS
logarithm of contrast sensitivity at a preset visual acuity level of 0.1 (= 2/20)
Time frame: at least two months after uneventful intraocular lens implantation
Reproducibilities of logVA
as operationalized by LOA (limits of agreement)
Time frame: at least two months after uneventful intraocular lens implantation
Resonse times of logCS
time interval between onset of stimulus presentation amd final response
Time frame: at least two months after uneventful intraocular lens implantation
Scanpath characteristics (I)
fixation duration
Time frame: at least two months after uneventful intraocular lens implantation
Scanpath characteristics (II)
fixation stability
Time frame: at least two months after uneventful intraocular lens implantation
Scanpath characteristics (III)
annotation to regions of interest (ROIs)
Time frame: at least two months after uneventful intraocular lens implantation
Scanpath characteristics (IV)
saccade amplitude
Time frame: at least two months after uneventful intraocular lens implantation
Self-evaluation (questionnaire) (i) distant vision with best distant correction
Distant vision (self-eval., vis. analogue scales: 0 = unsatisfactory ... 10 = optimal)
Time frame: at least two months after uneventful intraocular lens implantation
Self-evaluation (questionnaire) (i) intermediate vision with best distant correction
Intermed. vision (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal)
Time frame: at least two months after uneventful intraocular lens implantation
Self-evaluation (questionnaire) (i) mesopic vision with best distant correction
Mesopic vision (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal)
Time frame: at least two months after uneventful intraocular lens implantation
Self-evaluation (questionnaire) (i) glare sensitivity with best distant correction
Glare sensitivity (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal)
Time frame: at least two months after uneventful intraocular lens implantation
Self-evaluation (questionnaire) (i) General post-op vision with best distant corr.
Post-op vision (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal)
Time frame: at least two months after uneventful intraocular lens implantation
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Aalen University