JJ-EYHANCE: Intermediate Vision in a Driving Simulator Environment: Comparison of the J&J EYHANCE With a Conventional Monofoc. IOL
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
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Medical/ophthalmological history
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(Uncorrected and Best-corrected) visual acuity (RE,LE,BE) with remote and intermediate (66cm) 8 position LANDOLT C's.
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LANG I stereotest (near distance)
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Ocular alignment & ocular motility
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Efferent & afferent pupillomotor status
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Mesopic contrast sensitivity without/with glare (Optovist, VISTEC Inc./Olching/FRG)
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Intraocular straylight perception (Q-Quant, OCULUS Inc, Wetzlar/FRG)
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Slit lamp (anterior segment)
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Ophthalmoscope (central fundus and fixation)
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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)
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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
Arms and Interventions
| Arm | Intervention/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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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)
- 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
- Reproducibilities of logVA [at least two months after uneventful intraocular lens implantation]
as operationalized by LOA (limits of agreement)
- Resonse times of logCS [at least two months after uneventful intraocular lens implantation]
time interval between onset of stimulus presentation amd final response
- Scanpath characteristics (I) [at least two months after uneventful intraocular lens implantation]
fixation duration
- Scanpath characteristics (II) [at least two months after uneventful intraocular lens implantation]
fixation stability
- Scanpath characteristics (III) [at least two months after uneventful intraocular lens implantation]
annotation to regions of interest (ROIs)
- Scanpath characteristics (IV) [at least two months after uneventful intraocular lens implantation]
saccade amplitude
- 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)
- 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)
- 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)
- 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)
- 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
Inclusion Criteria:
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Informed consent
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S.p. (at least two months post surgery) bilateral uneventful IOL surgery (bilateral implantation of either EYHANCE IOL OR monofocal IOL)
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Ophthalmological history normal, except cataract and uneventful IOL surgery
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Distant visual high-contrast acuity > 20/25 in either eye
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Normal stereopsis (all figures of the LANG I random dot stereo test correctly recognized)
Exclusion Criteria:
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Age below 18 years
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Chronic eye disease (except cataract)
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History of ocular surgery (except complication-free IOL surgery)
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Visual pathway lesions
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Strabismus
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Applied Sciences, Study Course Ophthalmic Optics | Aalen | Baden-Württemberg | Germany | 73430 |
Sponsors and Collaborators
- Aalen University
- University Hospital Tuebingen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JJ-EY-AA_1