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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04059289
Acronym
JJ-EYHANCE
Enrollment
11
Registered
2019-08-16
Start date
2020-01-07
Completion date
2020-03-15
Last updated
2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Driving, Lenses, Intraocular, Near Vision, Pseudophakia

Keywords

glare, contrast sensitivity, driving simulator, intermediate visual acuity, pseudophakia, posterior chamber intraocular lenses, benchmark, straylight, nighttime driving

Brief 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.

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

Interventions

OTHERPosterior chamber intraocular lens (IOL)

This is NOT an interventional study; the intervention (surgical procedure) has been performed PRIOR to the inclusion in this study

Sponsors

University Hospital Tuebingen
CollaboratorOTHER
Aalen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
logVAat least two months after uneventful intraocular lens implantationlogarithm of visual acuity at preset low contrast level of 1:2.7 (logCS = 0.2)
logCSat least two months after uneventful intraocular lens implantationlogarithm of contrast sensitivity at a preset visual acuity level of 0.1 (= 2/20)

Secondary

MeasureTime frameDescription
Scanpath characteristics (I)at least two months after uneventful intraocular lens implantationfixation duration
Scanpath characteristics (II)at least two months after uneventful intraocular lens implantationfixation stability
Scanpath characteristics (III)at least two months after uneventful intraocular lens implantationannotation to regions of interest (ROIs)
Scanpath characteristics (IV)at least two months after uneventful intraocular lens implantationsaccade amplitude
Reproducibilities of logVAat least two months after uneventful intraocular lens implantationas operationalized by LOA (limits of agreement)
Self-evaluation (questionnaire) (i) intermediate vision with best distant correctionat least two months after uneventful intraocular lens implantationIntermed. vision (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal)
Self-evaluation (questionnaire) (i) mesopic vision with best distant correctionat least two months after uneventful intraocular lens implantationMesopic vision (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal)
Self-evaluation (questionnaire) (i) glare sensitivity with best distant correctionat least two months after uneventful intraocular lens implantationGlare sensitivity (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal)
Self-evaluation (questionnaire) (i) General post-op vision with best distant corr.at least two months after uneventful intraocular lens implantationPost-op vision (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal)
Self-evaluation (questionnaire) (i) distant vision with best distant correctionat least two months after uneventful intraocular lens implantationDistant vision (self-eval., vis. analogue scales: 0 = unsatisfactory ... 10 = optimal)
Resonse times of logCSat least two months after uneventful intraocular lens implantationtime interval between onset of stimulus presentation amd final response

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026