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

NCT ID: NCT04059289

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-07
• Study Completion Date: 2020-03-15

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

Conditions

Lenses, Intraocular; Pseudophakia; Near Vision; Driving

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intraocular lens type I

Tecnis EYHANCE IOL (Johnson \& Johnson, New Brunswick/USA)

Posterior chamber intraocular lens (IOL)

Intervention Type: OTHER

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

Intraocular lens type II

Clareon IOL (Alcon Pharma. Freiburg/FRG)

Posterior chamber intraocular lens (IOL)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Tecnis EYHANCE IOL (Johnson & Johnson, New Brunswick/USA); Clareon IOL (Alcon Pharma. Freiburg/FRG)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

Aalen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Applied Sciences, Study Course Ophthalmic Optics

Aalen, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

JJ-EY-AA_1

Identifier Type: -

Identifier Source: org_study_id