- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04059289
Intermediate Vision in a Driving Simulator Environment: Comparison of the J&J EYHANCE With a Conventional Monofoc. IOL (JJ-EYHANCE)
Intermediate Vision in a Driving Simulator Environment: Comparison of the New J&J EYHANCE IOL With a Conventional Monofocal IOL
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Baden-Württemberg
-
Aalen, Baden-Württemberg, Germany, 73430
- University of Applied Sciences, Study Course Ophthalmic Optics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intraocular lens type I
Tecnis EYHANCE IOL (Johnson & Johnson, New Brunswick/USA)
|
This is NOT an interventional study; the intervention (surgical procedure) has been performed PRIOR to the inclusion in this study
Other Names:
|
Intraocular lens type II
Clareon IOL (Alcon Pharma.
Freiburg/FRG)
|
This is NOT an interventional study; the intervention (surgical procedure) has been performed PRIOR to the inclusion in this study
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
logVA
Time Frame: 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)
|
at least two months after uneventful intraocular lens implantation
|
logCS
Time Frame: at least two months after uneventful intraocular lens implantation
|
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
Time Frame: at least two months after uneventful intraocular lens implantation
|
as operationalized by LOA (limits of agreement)
|
at least two months after uneventful intraocular lens implantation
|
Resonse times of logCS
Time Frame: at least two months after uneventful intraocular lens implantation
|
time interval between onset of stimulus presentation amd final response
|
at least two months after uneventful intraocular lens implantation
|
Scanpath characteristics (I)
Time Frame: at least two months after uneventful intraocular lens implantation
|
fixation duration
|
at least two months after uneventful intraocular lens implantation
|
Scanpath characteristics (II)
Time Frame: at least two months after uneventful intraocular lens implantation
|
fixation stability
|
at least two months after uneventful intraocular lens implantation
|
Scanpath characteristics (III)
Time Frame: at least two months after uneventful intraocular lens implantation
|
annotation to regions of interest (ROIs)
|
at least two months after uneventful intraocular lens implantation
|
Scanpath characteristics (IV)
Time Frame: at least two months after uneventful intraocular lens implantation
|
saccade amplitude
|
at least two months after uneventful intraocular lens implantation
|
Self-evaluation (questionnaire) (i) distant vision with best distant correction
Time Frame: at least two months after uneventful intraocular lens implantation
|
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
Time Frame: at least two months after uneventful intraocular lens implantation
|
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
Time Frame: at least two months after uneventful intraocular lens implantation
|
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
Time Frame: at least two months after uneventful intraocular lens implantation
|
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.
Time Frame: at least two months after uneventful intraocular lens implantation
|
Post-op vision (self-eval., vis.
analog.
scales: 0 = unsatisfactory ... 10 = optimal)
|
at least two months after uneventful intraocular lens implantation
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JJ-EY-AA_1
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