Lenses, IntraocularJJ-EYHANCENCT04059289
Intermediate Vision in a Driving Simulator Environment: Comparison of the J&J EYHANCE With a Conventional Monofoc. IOL
An observational study of Lenses, Intraocular and Pseudophakia, run by Aalen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lenses, Intraocular, Pseudophakia, Near Vision
- What is being tested?
- Posterior chamber intraocular lens (IOL)
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jan 2020to 15 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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)
Who may be able to join
- 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)
Who cannot join
- Age below 18 years
- Chronic eye disease (except cataract)
- History of ocular surgery (except complication-free IOL surgery)
- Visual pathway lesions
- Strabismus
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Applied Sciences, Study Course Ophthalmic Optics
Aalen, Baden-Wurttemberg, 73430
About this study
Official title: 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.
Read the 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
- Conditions
- Lenses, Intraocular, Pseudophakia, Near Vision, Driving
- Being tested
- Posterior chamber intraocular lens (IOL)
- Keywords
- glare, contrast sensitivity, driving simulator, intermediate visual acuity, pseudophakia, posterior chamber intraocular lenses, benchmark, straylight, nighttime driving
- Medical subject headings
- Pseudophakia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior chamber intraocular lens (IOL)Other
Also called Tecnis EYHANCE IOL (Johnson & Johnson, New Brunswick/USA), 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
| Study group | Role | What they receive |
|---|---|---|
| Intraocular lens type I | Tecnis EYHANCE IOL (Johnson \& Johnson, New Brunswick/USA) Receives: Other: Posterior chamber intraocular lens (IOL) | |
| Intraocular lens type II | Clareon IOL (Alcon Pharma. Freiburg/FRG) Receives: Other: Posterior chamber intraocular lens (IOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
logVA
logarithm of visual acuity at preset low contrast level of 1:2.7 (logCS = 0.2)
Measured: 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)
Measured: at least two months after uneventful intraocular lens implantation
Secondary outcomes (11)
Reproducibilities of logVA
as operationalized by LOA (limits of agreement)
Measured: at least two months after uneventful intraocular lens implantation
Resonse times of logCS
time interval between onset of stimulus presentation amd final response
Measured: at least two months after uneventful intraocular lens implantation
Scanpath characteristics (I)
fixation duration
Measured: at least two months after uneventful intraocular lens implantation
Scanpath characteristics (II)
fixation stability
Measured: at least two months after uneventful intraocular lens implantation
Scanpath characteristics (III)
annotation to regions of interest (ROIs)
Measured: at least two months after uneventful intraocular lens implantation
Scanpath characteristics (IV)
saccade amplitude
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at least two months after uneventful intraocular lens implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start7 Jan 2020
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lenses, IntraocularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalen University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059289
- Sponsor's protocol ID
- JJ-EY-AA_1
- Acronym
- JJ-EYHANCE
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate Vision in a Driving Simulator Environment: Comparison of the New J&J EYHANCE IOL With a Conventional Monofocal IOL
- ClinicalTrials.gov ID
- NCT04059289
- Acronym / sponsor ID
- JJ-EYHANCE / JJ-EY-AA_1
- Conditions
- Lenses, Intraocular, Pseudophakia, Near Vision, Driving
- Keywords
- glare, contrast sensitivity, driving simulator, intermediate visual acuity, pseudophakia, posterior chamber intraocular lenses, benchmark, straylight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Aalen UniversityUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraocular lens type I | – | Other: Posterior chamber intraocular lens (IOL)Tecnis EYHANCE IOL (Johnson \& Johnson, New Brunswick/USA) |
| Intraocular lens type II | – | Other: Posterior chamber intraocular lens (IOL)Clareon IOL (Alcon Pharma. Freiburg/FRG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- Age below 18 years
- Chronic eye disease (except cataract)
- History of ocular surgery (except complication-free IOL surgery)
- Visual pathway lesions
- Strabismus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior chamber intraocular lens (IOL)Also: Tecnis EYHANCE IOL (Johnson & Johnson, New Brunswick/USA), 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 | Intraocular lens type I, Intraocular lens type II |
Primary outcome
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)
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)
11 secondary outcomes
Reproducibilities of logVA
Time frame: at least two months after uneventful intraocular lens implantation
Resonse times of logCS
Time frame: at least two months after uneventful intraocular lens implantation
Scanpath characteristics (I)
Time frame: at least two months after uneventful intraocular lens implantation
Scanpath characteristics (II)
Time frame: at least two months after uneventful intraocular lens implantation
Scanpath characteristics (III)
Time frame: at least two months after uneventful intraocular lens implantation
Scanpath characteristics (IV)
Time frame: 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
Self-evaluation (questionnaire) (i) intermediate vision with best distant correction
Time frame: 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
Self-evaluation (questionnaire) (i) glare sensitivity with best distant correction
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lenses, Intraocular and Pseudophakia, run by Aalen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
logVA (time frame: at least two months after uneventful intraocular lens implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.