Clinical trial NCT04059289: Intermediate Vision in a Driving Simulator Environment: Comparison of the J&J EYHANCE With a Conventional Monofoc. IOL
Official title: Intermediate Vision in a Driving Simulator Environment: Comparison of the New J&J EYHANCE IOL With a Conventional Monofocal IOL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lenses, Intraocular
Pseudophakia
Near Vision
Driving
Keywords: glare
contrast sensitivity
driving simulator
intermediate visual acuity
pseudophakia
posterior chamber intraocular lenses
benchmark
straylight
nighttime driving
Lead sponsor: Aalen University
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2019-08-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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

Eligibility criteria: 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

Primary outcomes:
measure: logVA
timeFrame: at least two months after uneventful intraocular lens implantation
measure: logCS
timeFrame: at least two months after uneventful intraocular lens implantation
Secondary outcomes:
measure: Reproducibilities of logVA
timeFrame: at least two months after uneventful intraocular lens implantation
measure: Resonse times of logCS
timeFrame: at least two months after uneventful intraocular lens implantation
measure: Scanpath characteristics (I)
timeFrame: at least two months after uneventful intraocular lens implantation
measure: Scanpath characteristics (II)
timeFrame: at least two months after uneventful intraocular lens implantation
measure: Scanpath characteristics (III)
timeFrame: at least two months after uneventful intraocular lens implantation
measure: Scanpath characteristics (IV)
timeFrame: at least two months after uneventful intraocular lens implantation
measure: Self-evaluation (questionnaire) (i) distant vision with best distant correction
timeFrame: at least two months after uneventful intraocular lens implantation
measure: Self-evaluation (questionnaire) (i) intermediate vision with best distant correction
timeFrame: at least two months after uneventful intraocular lens implantation
measure: Self-evaluation (questionnaire) (i) mesopic vision with best distant correction
timeFrame: at least two months after uneventful intraocular lens implantation
measure: Self-evaluation (questionnaire) (i) glare sensitivity with best distant correction
timeFrame: at least two months after uneventful intraocular lens implantation
measure: Self-evaluation (questionnaire) (i) General post-op vision with best distant corr.
timeFrame: at least two months after uneventful intraocular lens implantation
Other outcomes:
Locations:
city: Aalen
country: Germany
facility: University of Applied Sciences, Study Course Ophthalmic Optics
state: Baden-Württemberg
Study officials:
References: