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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Lenses, Intraocular, Pseudophakia, Near Vision, Driving

Intervention / Treatment
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* Other: Posterior chamber intraocular lens (IOL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent S.p. (at least two months post surgery) bilateral uneventful IOL surgery (bilateral implantation of either EYHANCE IOL OR monofocal IOL) Ophthalmological history normal, except cataract and uneventful IOL surgery Distant visual high-contrast acuity > 20/25 in either eye Normal stereopsis (all figures of the LANG I random dot stereo test correctly recognized) Exclusion Criteria: Age below 18 years Chronic eye disease (except cataract) History of ocular surgery (except complication-free IOL surgery) Visual pathway lesions Strabismus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intraocular lens type I<br>Tecnis EYHANCE IOL (Johnson & Johnson, New Brunswick/USA) | Other: Posterior chamber intraocular lens (IOL)<br>* This is NOT an interventional study; the intervention (surgical procedure) has been performed PRIOR to the inclusion in this study<br>* Other names: Clareon IOL (Alcon Pharma. Freiburg/FRG);|
| Intraocular lens type II<br>Clareon IOL (Alcon Pharma. Freiburg/FRG) | Other: Posterior chamber intraocular lens (IOL)<br>* This is NOT an interventional study; the intervention (surgical procedure) has been performed PRIOR to the inclusion in this study<br>* Other names: Clareon IOL (Alcon Pharma. Freiburg/FRG);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| logVA | logarithm of visual acuity at preset low contrast level of 1:2.7 (logCS = 0.2) | 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) | at least two months after uneventful intraocular lens implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibilities of logVA | as operationalized by LOA (limits of agreement) | at least two months after uneventful intraocular lens implantation | 
| Resonse times of logCS | time interval between onset of stimulus presentation amd final response | at least two months after uneventful intraocular lens implantation | 
| Scanpath characteristics (I) | fixation duration | at least two months after uneventful intraocular lens implantation | 
| Scanpath characteristics (II) | fixation stability | at least two months after uneventful intraocular lens implantation | 
| Scanpath characteristics (III) | annotation to regions of interest (ROIs) | at least two months after uneventful intraocular lens implantation | 
| Scanpath characteristics (IV) | saccade amplitude | 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) | 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) | 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) | 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) | 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) | at least two months after uneventful intraocular lens implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glare, contrast sensitivity, driving simulator, intermediate visual acuity, pseudophakia, posterior chamber intraocular lenses, benchmark, straylight, nighttime driving