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

Pseudophakia Clinical Trial

— JJ-EYHANCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059289
• Other study ID #: JJ-EY-AA_1
• Status: Completed
• Start date: January 7, 2020
• Est. completion date: March 15, 2020

Study information

• Verified date: August 2019
• Source: Aalen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Driving
• Lenses, Intraocular
• Near Vision
• Pseudophakia

Intervention

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

Locations

Country	Name	City	State
Germany	University of Applied Sciences, Study Course Ophthalmic Optics	Aalen	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Aalen University	University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Reproducibilities of logVA	as operationalized by LOA (limits of agreement)	at least two months after uneventful intraocular lens implantation
Secondary	Resonse times of logCS	time interval between onset of stimulus presentation amd final response	at least two months after uneventful intraocular lens implantation
Secondary	Scanpath characteristics (I)	fixation duration	at least two months after uneventful intraocular lens implantation
Secondary	Scanpath characteristics (II)	fixation stability	at least two months after uneventful intraocular lens implantation
Secondary	Scanpath characteristics (III)	annotation to regions of interest (ROIs)	at least two months after uneventful intraocular lens implantation
Secondary	Scanpath characteristics (IV)	saccade amplitude	at least two months after uneventful intraocular lens implantation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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