Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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)
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraocular lens type I | Tecnis EYHANCE IOL (Johnson & Johnson, New Brunswick/USA) |
| |
| Intraocular lens type II | Clareon IOL (Alcon Pharma. Freiburg/FRG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior chamber intraocular lens (IOL) | Other | This is NOT an interventional study; the intervention (surgical procedure) has been performed PRIOR to the inclusion in this study |
| Measure | Description | Time Frame |
|---|---|---|
| logVA | 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 | logarithm of contrast sensitivity at a preset visual acuity level of 0.1 (= 2/20) | at least two months after uneventful intraocular lens implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibilities of logVA | as operationalized by LOA (limits of agreement) | at least two months after uneventful intraocular lens implantation |
| Resonse times of logCS | time interval between onset of stimulus presentation amd final response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Applied Sciences, Study Course Ophthalmic Optics | Aalen | Baden-Wurttemberg | 73430 | Germany |
Not provided
| ID | Term |
|---|---|
| D019591 | Pseudophakia |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Two types of intraocular lenses
|
| at least two months after uneventful intraocular lens implantation |
| Scanpath characteristics (I) | fixation duration | at least two months after uneventful intraocular lens implantation |
| Scanpath characteristics (II) | fixation stability | at least two months after uneventful intraocular lens implantation |
| Scanpath characteristics (III) | annotation to regions of interest (ROIs) | at least two months after uneventful intraocular lens implantation |
| Scanpath characteristics (IV) | saccade amplitude | at least two months after uneventful intraocular lens implantation |
| Self-evaluation (questionnaire) (i) distant vision with best distant correction | 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 | 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 | 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 | 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. | Post-op vision (self-eval., vis. analog. scales: 0 = unsatisfactory ... 10 = optimal) | at least two months after uneventful intraocular lens implantation |