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

Sponsor
Aalen University (Other)
Overall Status
Completed
CT.gov ID
NCT04059289
Collaborator
University Hospital Tuebingen (Other)
11
Enrollment
1
Location
2.2
Actual Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Posterior chamber intraocular lens (IOL)

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

Study Design

Study Type:
Observational
Actual Enrollment :
11 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Intermediate Vision in a Driving Simulator Environment: Comparison of the New J&J EYHANCE IOL With a Conventional Monofocal IOL
Actual Study Start Date :
Jan 7, 2020
Actual Primary Completion Date :
Mar 15, 2020
Actual Study Completion Date :
Mar 15, 2020

Arms and Interventions

ArmIntervention/Treatment
Intraocular lens type I

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

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
Other Names:
  • Tecnis EYHANCE IOL (Johnson & Johnson, New Brunswick/USA)
  • Clareon IOL (Alcon Pharma. Freiburg/FRG)
  • Intraocular lens type II

    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
    Other Names:
  • Tecnis EYHANCE IOL (Johnson & Johnson, New Brunswick/USA)
  • Clareon IOL (Alcon Pharma. Freiburg/FRG)
  • Outcome Measures

    Primary Outcome Measures

    1. logVA [at least two months after uneventful intraocular lens implantation]

      logarithm of visual acuity at preset low contrast level of 1:2.7 (logCS = 0.2)

    2. logCS [at least two months after uneventful intraocular lens implantation]

      logarithm of contrast sensitivity at a preset visual acuity level of 0.1 (= 2/20)

    Secondary Outcome Measures

    1. Reproducibilities of logVA [at least two months after uneventful intraocular lens implantation]

      as operationalized by LOA (limits of agreement)

    2. Resonse times of logCS [at least two months after uneventful intraocular lens implantation]

      time interval between onset of stimulus presentation amd final response

    3. Scanpath characteristics (I) [at least two months after uneventful intraocular lens implantation]

      fixation duration

    4. Scanpath characteristics (II) [at least two months after uneventful intraocular lens implantation]

      fixation stability

    5. Scanpath characteristics (III) [at least two months after uneventful intraocular lens implantation]

      annotation to regions of interest (ROIs)

    6. Scanpath characteristics (IV) [at least two months after uneventful intraocular lens implantation]

      saccade amplitude

    7. Self-evaluation (questionnaire) (i) distant vision with best distant correction [at least two months after uneventful intraocular lens implantation]

      Distant vision (self-eval., vis. analogue scales: 0 = unsatisfactory ... 10 = optimal)

    8. Self-evaluation (questionnaire) (i) intermediate vision with best distant correction [at least two months after uneventful intraocular lens implantation]

      Intermed. vision (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal)

    9. Self-evaluation (questionnaire) (i) mesopic vision with best distant correction [at least two months after uneventful intraocular lens implantation]

      Mesopic vision (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal)

    10. Self-evaluation (questionnaire) (i) glare sensitivity with best distant correction [at least two months after uneventful intraocular lens implantation]

      Glare sensitivity (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal)

    11. Self-evaluation (questionnaire) (i) General post-op vision with best distant corr. [at least two months after uneventful intraocular lens implantation]

      Post-op vision (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Applied Sciences, Study Course Ophthalmic OpticsAalenBaden-WürttembergGermany73430

    Sponsors and Collaborators

    • Aalen University
    • University Hospital Tuebingen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aalen University
    ClinicalTrials.gov Identifier:
    NCT04059289
    Other Study ID Numbers:
    • JJ-EY-AA_1
    First Posted:
    Aug 16, 2019
    Last Update Posted:
    Mar 31, 2020
    Last Verified:
    Aug 1, 2019

    Study Results

    No Results Posted as of Mar 31, 2020