CataractContrastValNCT03169855
Validation of Mesopic and Photopic Contrast Vision Tests With Respect to Nighttime Driving Ability
An observational study of Cataract and Traffic Accident, run by Aalen University at 1 site in Germany.
Trial summary
A) The main purposes of this study are (i) to develop a related virtual reality (VR) environment in order to judge the nighttime driving ability under mesopic and under glare conditions (ophthalmologically healthy subjects and patients with incipient to intermediate cataract, i.e. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Traffic Accident, Vision Disorders
- What is being tested?
- Slit lamp (LOCS III Score)
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2017to 31 Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ophthalmologically healthy subjects and patients with incipient to intermediate cataract.
Who may be able to join
- age ≥ 18 years (preferred: age, exceeding 50 yrs.)
- Minimum distant visual acuity (with habitual correction) 0.8 (16/20, single optotypes, LANDOLT C chart for presentation of high contrast optotypes according to DIN 58220 - Part 3/ISO 10938 (Visus GmbH, Stuttgart/Germany)
- ametropia maximum spherical ametropia sph ±8.00 dpt maximum maximum astigmatism cyl 2.00 dpt
- normal (age-corrected) visual field
- clear refractive media OR incipient to intermediate cataract
- informed consent
Who cannot join
- epilepsy / psychiatric disorders
- drugs, interfering with reaction time and/or with visual acuity or with refractive status of the eye
- deficient driving license
- yearly mileage less than 3000 km/y (less than 1.864 miles/y)
- ophthalmological exclusion criteria: all ophthalmological diseases or abnormalities, with the exception of those, listed in the above-mentioned inclusion criteria
- amblyopia
Show all 21Show fewer
- strabismus
- ocular motility disorders
- nystagmus
- double vision
- albinism
- glaucoma / IOP exceeding 22 mmHg
- shallow anterior chamber/risk of angle closure glaucoma (van HERICK grade less than 2)
- macular diseases / maculopathy
- diabetic retinopathy (blood sugar-related retinal disease)
- status post severe eye injuries
- eye surgery within the last three months (, related to the time point of recruitment)
- Infectious diseases (conjunctivitis, corneal inflammation, uveitis)
- very dry eyes (sicca symptoms)
- drugs inducing miosis
- any other eye disorders that affect the image quality
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: Validation of Mesopic and Photopic Contrast Vision Tests With Respect to Nighttime Driving Ability (ContrastVal) - Influence of Dynamic Glare on (Aged) Motorist (With/Without Media Opacities)
- The main purposes of this study are (i) to develop a related virtual reality (VR) environment in order to judge the nighttime driving ability under mesopic and under glare conditions (ophthalmologically healthy subjects and patients with incipient to intermediate cataract, i.e. opacities of the human lens, will participate in this study), (ii) to validate the above-mentioned VR environment with respect to a related on-road driving scenario under mesopic and glare conditions, (iii) to validate clinical photopic and mesopic contrast vision tests and glare tests with respect to the prediction of nighttime driving ability, (iv) to assess the test retest reliability of clinical photopic and mesopic contrast vision tests
- Background:
An intact mesopic vision and a glare sensitivity within a normal range are essential pre-requisites for safe driving at nighttime (DOG \& BVA, 2011). Anderson \& Holiday (1995) have shown that (simulated) opacities of the refractive media (with only minor effects on daytime visual acuity) induce a pronounced impairment of contrast sensitivity under nighttime conditions. Especially under glare conditions by the headlights of traffic on the opposite lane or by stationary street illumination, an impairment of the mesopic vision may cause traffic hazards. The prevalence of impairments of the central visual acuity, the mesopic vision and the glare sensitivity is significantly higher for subjects being involved in nighttime traffic accidents (Lachenmayr, 1998). Furthermore, these impairments occur more frequently in aged drivers and are, among others, related to an increase of age-related media opacities (Aulhorn \& Harms, 1970, Babizhayev, 2003). Due to the demographic change, the relevance of nighttime driving ability is increasing in the next years since more and more aged employees will participate at the motorized traffic at night.
The German Fahrerlaubnisverordnung (FEV i.e. driving license regulation) specifies pass/fail criteria with regard to mesopic vision and glare sensitivity. The luminance level during nighttime driving is usually between 0.01 and 1 cd/m^2, and therefore can be attributed to the level of mesopic vision. However, over the last years, the attempt was made to introduce photopic contrast sensitivity test to diagnose nighttime driving ability (i.e. testing of contrast vision under daytime conditions without time consuming adaptation procedures). Current research aims at investigating the relationship between contrast tests under various luminance conditions (Wilhelm et al, 2013). It is questionable, whether photopic tests are at all reliable predictors with regard to nighttime driving (Gramberg-Danielsen et al., 1984, Hertenstein et al., Graefe´s Archive of Ophthalmology, 2016).
Read the detailed description
Subjects and Methods Adult patients with a distant binocular visual acuity of ≥ 0.8 (≥ 16/20; habitual correction) and healthy control subjects will be included in this explorative study after informed consent.
The study will be subdivided in the following (three) parts:
Part 1: Validation of the Aalen driving simulator set-up (ten patients with incipient to moderate cataract, i.e. opacities of the human lens of varying localization and of various degree of expression in at least one eye and ten age- and gender-correlated ophthalmologically healthy control subjects will be enrolled) Part 1.1.: Comprehensive ophthalmological/optical examination (Aalen University of Applied Sciences) including a detailed ophthalmological and medical history.
Part 1.2.: Baseline driving simulator test under mesopic conditions with/without glare under simulated static/simulated driving conditions (Aalen University of Applied Sciences) Part 1.3.: Baseline on road test under mesopic conditions with/without glare, under on road static/on road driving conditions (Aalen University of Applied Sciences) (If possible, the sequence of Part 1.2. and Part 1.3. will be randomly assigned.)
Part 2: Advanced driving simulator test (twenty patients with incipient to moderate cataract, i.e. opacities of the human lens of varying localization and of various degree of expression in at least one eye and twenty age- and gender-correlated ophthalmologically healthy control subjects will be enrolled. Subjects being enrolled in Part 1, will be asked to participate also at Part 2 and Part 3.) Part 2.1.: Comprehensive ophthalmological/optical examination of all (newly) enrolled patients and subjects who have not already been examined in Part. 1.1. (Aalen University of Applied Sciences).
Part 2.2.: Advanced driving simulator test under photopic and under mesopic simulated driving with and without glare (Würzburg Institute for Traffic Sciences = WIVW) in order to investigate the influence of glare on the driving behavior
Part 3: Representative driving simulator test (The [altogether fourty] subjects, enrolled in Part 2, will be enrolled in this part of the study.) Driving simulator test under photopic and mesopic conditions in oder to investigate glare on representative driving situations. Driving performance will be evaluated highly-standardized and partially automated on different parameters of operational and tactical driving behavior (S.A.F.E., Würzburg Institute for Traffic Sciences = WIVW).
Pass/fail rates are specified as described in the related manuals of the instruments. With regard to visual acuity measurements and assessment of mesopic contrast vision without/with glare, results are rated according to DIN 58220 - Part 3/ISO 10938: If less than three out of five subsequent presentations of an eight-position LANDOLT C (with two oblique and three horizontal/vertical gap locations in random sequence) are correctly identified, the session is rated as failed. Overlooking/missing reactions to obstacles (pedestrian [display dummy with dark clothing]/wild boar at the right roadside) are rated as failed.
For mesopic contrast vision testing, single LANDOLT optotpyes (visual acuity level 0.1 = 2/20) with the contrast levels (1:2, 1:5 and 1:23, respectively, according to AULHORN/HARMS) are presented via the Optovist Instrument (Vistec, Inc., Manching/Germany) or via the head up display (HUD) of the simulator vehicle/on road vehicle.
Photopic and mesopic contrast vision tests (without glare) are repeated once in order to assess the test retest variability of the related test procedure.
- LANDOLT C chart for presentation of high contrast optotypes according to DIN 58220 - Part 3/ISO 10938 (Visus GmbH, Stuttgart/Germany)
- Assessment of low contrast visual acuity using FrACT (Freiburg Visual Acuity Test, internet version 3.8.1)
- Assessment of photopic contrast sensitivity, using the MARS Letter Contrast Sensitivity Test (The Mars Perceptrix Corporation, NY 10514-2523,USA)
- Assessment of mesopic contrast sensitivity, using the OPTOVIST (VISTEC, Manching/FRG)
- Judgment of intraocular straylight, using the C-Quant (Straylight meter, OCULUS, Dutenhofen/FRG)
- Classification of human crystalline lens opacities, using the BQ 900 slitlamp (HAAG-STREIT, Köniz/CH), digital photography with dilated pupils, applying the LOCS III score
- Densitometry of the crystalline lens, using the Pentacam HR (OCULUS Inc., Dutenhofen/FRG)
- Digital Fundus Photography with dilated pupils (WX3D fundus camera, KOWA Optimed Deutschland GmbH, Düsseldorf/FRG)
- Aalen driving simulator: Two high performance VELVET planetarium projectors (Fa. ZEISS, Jena/FRG), AUDI A4 (AUDI Inc., Ingolstadt/FRG) with digital display and re-equipped (BFFT, Gaimersheim/FRG) with externally controllable head up display (HUD) for presentation of LANDOLT Cs with varying contrast levels, SILAB virtual reality environment (WIVW, Veitshöchheim/FRG), two mobile glare sources (LED arrays)
- Aalen on road parcours: AUDI A4 (AUDI Inc., Ingolstadt/FRG) with digital display, with externally controllable head up display (HUD, VW AG, Wolfsburg/FRG)) for presentation of LANDOLT Cs with varying contrast levels and equipped with dual brake (VEIGEL GmbH + Co KG, Künzelsau/FRG)
- Conditions
- Cataract, Traffic Accident, Vision Disorders, Driving Impaired
- Being tested
- Slit lamp (LOCS III Score)
- Keywords
- Traffic Ophthalmology, Glare, Cataract, Nighttime driving, contrast sensitivity, mesopic vision
- Medical subject headings
- Cataract, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slit lamp (LOCS III Score)Diagnostic test
Also called Oculus Pentacam (Scheimpflug procedure, densitometry)
Diagnostic procedure only
| Study group | Role | What they receive |
|---|---|---|
| Refractive media opacities: present | Refractive media opacities: present | |
| Refractive media opacities: absent | Refractive media opacities: absent Receives: Diagnostic Test: Slit lamp (LOCS III Score) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pass/fail rate (i.e. ratio of "no. of subjects passed" by "total no. of participants") with respect to a vision-related driving ability test
Pass/fail rates will be assessed for vision related driving ability tests:
(i) clinical photopic/mesopic contrast vision tests, (ii) glare tests, (iii) of driving simulator tests under mesopic conditions with and without glare, and (iv) on-road tests under mesopic conditions with and without glare
Measured: From date of "first subject in" to date of "last subject out", i.e. over an 18 months period
Secondary outcomes (4)
Rank of tested subjects with respect to a vision-related driving ability test
Rank/i.e. sequence of tested subjects with respect to the results of a vision-related driving ability test [see clauses (i) to (iv), Outcome 1]
Measured: From date of "first subject in" to date of "last subject out", i.e. over an 18 months period
Test-retest reliability, expressed as "limits of agreement" (LOA) of a clinical contrast vision test
Test-retest reliability of a clinical photopic/mesopic contrast vision test [see clauses (i) and (ii), Outcome 1]
Measured: From date of "first subject in" to date of "last subject out", i.e. over an 18 months period
Response time (in milliseconds) regarding to the gap recognition of a standardized optotype
Response time regarding gap recognition of a standardized optotype (8 position LANDOLT C) with three contrast levels, presented via the head up display
Measured: From date of "first subject in" to date of "last subject out", i.e. over an 18 months period
Intensity of driving simulator sickness, assessed by a questionnaire
Intensity of driving simulator sickness, assessed by a questionnaire
Measured: From date of "first subject in" to date of "last subject out", i.e. over an 18 months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start2 May 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalen University
- Sponsor type
- University, hospital or other
- Collaborators
- DGUV (Deutsche Gesetzliche Unfallversicherung/German Social Accident Insurance Institutions), Study Course Ophthalmic Optics and Optometry, University of Applied Sciences Aalen, Study Course Mechatronics, University of Applied Sciences Aalen, Steinbeis Transferzentrum AWFE, University of Applied Sciences Aalen, Würzburg Institute for Traffic Sciences GmbH
- Responsible party
- Sponsor
- Investigators
- Ulrich Schiefer, Prof. Dr., Principal investigator, Aalen University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169855
- Sponsor's protocol ID
- F-2015-044#A1
- Acronym
- ContrastVal
- Status last verified
- Jan 2019
- First submitted
- 19 May 2017
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Mesopic and Photopic Contrast Vision Tests With Respect to Nighttime Driving Ability (ContrastVal) - Influence of Dynamic Glare on (Aged) Motorist (With/Without Media Opacities)
- ClinicalTrials.gov ID
- NCT03169855
- Acronym / sponsor ID
- ContrastVal / F-2015-044#A1
- Conditions
- Cataract, Traffic Accident, Vision Disorders, Driving Impaired
- Keywords
- Traffic Ophthalmology, Glare, Cataract, Nighttime driving, contrast sensitivity, mesopic vision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Aalen UniversityUniversity, hospital or other
- Collaborators
- DGUV (Deutsche Gesetzliche Unfallversicherung/German Social Accident Insurance Institutions), Study Course Ophthalmic Optics and Optometry, University of Applied Sciences Aalen, Study Course Mechatronics, University of Applied Sciences Aalen, Steinbeis Transferzentrum AWFE, University of Applied Sciences Aalen, Würzburg Institute for Traffic Sciences GmbH
- Study start
- 2 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 May 2017 (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.
- The main purposes of this study are (i) to develop a related virtual reality (VR) environment in order to judge the nighttime driving ability under mesopic and under glare conditions (ophthalmologically healthy subjects and patients with incipient to intermediate cataract, i.e. opacities of the human lens, will participate in this study), (ii) to validate the above-mentioned VR environment with respect to a related on-road driving scenario under mesopic and glare conditions, (iii) to validate clinical photopic and mesopic contrast vision tests and glare tests with respect to the prediction of nighttime driving ability, (iv) to assess the test retest reliability of clinical photopic and mesopic contrast vision tests
- Background:
An intact mesopic vision and a glare sensitivity within a normal range are essential pre-requisites for safe driving at nighttime (DOG \& BVA, 2011). Anderson \& Holiday (1995) have shown that (simulated) opacities of the refractive media (with only minor effects on daytime visual acuity) induce a pronounced impairment of contrast sensitivity under nighttime conditions. Especially under glare conditions by the headlights of traffic on the opposite lane or by stationary street illumination, an impairment of the mesopic vision may cause traffic hazards. The prevalence of impairments of the central visual acuity, the mesopic vision and the glare sensitivity is significantly higher for subjects being involved in nighttime traffic accidents (Lachenmayr, 1998). Furthermore, these impairments occur more frequently in aged drivers and are, among others, related to an increase of age-related media opacities (Aulhorn \& Harms, 1970, Babizhayev, 2003). Due to the demographic change, the relevance of nighttime driving ability is increasing in the next years since more and more aged employees will participate at the motorized traffic at night.
The German Fahrerlaubnisverordnung (FEV i.e. driving license regulation) specifies pass/fail criteria with regard to mesopic vision and glare sensitivity. The luminance level during nighttime driving is usually between 0.01 and 1 cd/m^2, and therefore can be attributed to the level of mesopic vision. However, over the last years, the attempt was made to introduce photopic contrast sensitivity test to diagnose nighttime driving ability (i.e. testing of contrast vision under daytime conditions without time consuming adaptation procedures). Current research aims at investigating the relationship between contrast tests under various luminance conditions (Wilhelm et al, 2013). It is questionable, whether photopic tests are at all reliable predictors with regard to nighttime driving (Gramberg-Danielsen et al., 1984, Hertenstein et al., Graefe´s Archive of Ophthalmology, 2016).
Detailed description
Subjects and Methods Adult patients with a distant binocular visual acuity of ≥ 0.8 (≥ 16/20; habitual correction) and healthy control subjects will be included in this explorative study after informed consent.
The study will be subdivided in the following (three) parts:
Part 1: Validation of the Aalen driving simulator set-up (ten patients with incipient to moderate cataract, i.e. opacities of the human lens of varying localization and of various degree of expression in at least one eye and ten age- and gender-correlated ophthalmologically healthy control subjects will be enrolled) Part 1.1.: Comprehensive ophthalmological/optical examination (Aalen University of Applied Sciences) including a detailed ophthalmological and medical history.
Part 1.2.: Baseline driving simulator test under mesopic conditions with/without glare under simulated static/simulated driving conditions (Aalen University of Applied Sciences) Part 1.3.: Baseline on road test under mesopic conditions with/without glare, under on road static/on road driving conditions (Aalen University of Applied Sciences) (If possible, the sequence of Part 1.2. and Part 1.3. will be randomly assigned.)
Part 2: Advanced driving simulator test (twenty patients with incipient to moderate cataract, i.e. opacities of the human lens of varying localization and of various degree of expression in at least one eye and twenty age- and gender-correlated ophthalmologically healthy control subjects will be enrolled. Subjects being enrolled in Part 1, will be asked to participate also at Part 2 and Part 3.) Part 2.1.: Comprehensive ophthalmological/optical examination of all (newly) enrolled patients and subjects who have not already been examined in Part. 1.1. (Aalen University of Applied Sciences).
Part 2.2.: Advanced driving simulator test under photopic and under mesopic simulated driving with and without glare (Würzburg Institute for Traffic Sciences = WIVW) in order to investigate the influence of glare on the driving behavior
Part 3: Representative driving simulator test (The [altogether fourty] subjects, enrolled in Part 2, will be enrolled in this part of the study.) Driving simulator test under photopic and mesopic conditions in oder to investigate glare on representative driving situations. Driving performance will be evaluated highly-standardized and partially automated on different parameters of operational and tactical driving behavior (S.A.F.E., Würzburg Institute for Traffic Sciences = WIVW).
Pass/fail rates are specified as described in the related manuals of the instruments. With regard to visual acuity measurements and assessment of mesopic contrast vision without/with glare, results are rated according to DIN 58220 - Part 3/ISO 10938: If less than three out of five subsequent presentations of an eight-position LANDOLT C (with two oblique and three horizontal/vertical gap locations in random sequence) are correctly identified, the session is rated as failed. Overlooking/missing reactions to obstacles (pedestrian [display dummy with dark clothing]/wild boar at the right roadside) are rated as failed.
For mesopic contrast vision testing, single LANDOLT optotpyes (visual acuity level 0.1 = 2/20) with the contrast levels (1:2, 1:5 and 1:23, respectively, according to AULHORN/HARMS) are presented via the Optovist Instrument (Vistec, Inc., Manching/Germany) or via the head up display (HUD) of the simulator vehicle/on road vehicle.
Photopic and mesopic contrast vision tests (without glare) are repeated once in order to assess the test retest variability of the related test procedure.
- LANDOLT C chart for presentation of high contrast optotypes according to DIN 58220 - Part 3/ISO 10938 (Visus GmbH, Stuttgart/Germany)
- Assessment of low contrast visual acuity using FrACT (Freiburg Visual Acuity Test, internet version 3.8.1)
- Assessment of photopic contrast sensitivity, using the MARS Letter Contrast Sensitivity Test (The Mars Perceptrix Corporation, NY 10514-2523,USA)
- Assessment of mesopic contrast sensitivity, using the OPTOVIST (VISTEC, Manching/FRG)
- Judgment of intraocular straylight, using the C-Quant (Straylight meter, OCULUS, Dutenhofen/FRG)
- Classification of human crystalline lens opacities, using the BQ 900 slitlamp (HAAG-STREIT, Köniz/CH), digital photography with dilated pupils, applying the LOCS III score
- Densitometry of the crystalline lens, using the Pentacam HR (OCULUS Inc., Dutenhofen/FRG)
- Digital Fundus Photography with dilated pupils (WX3D fundus camera, KOWA Optimed Deutschland GmbH, Düsseldorf/FRG)
- Aalen driving simulator: Two high performance VELVET planetarium projectors (Fa. ZEISS, Jena/FRG), AUDI A4 (AUDI Inc., Ingolstadt/FRG) with digital display and re-equipped (BFFT, Gaimersheim/FRG) with externally controllable head up display (HUD) for presentation of LANDOLT Cs with varying contrast levels, SILAB virtual reality environment (WIVW, Veitshöchheim/FRG), two mobile glare sources (LED arrays)
- Aalen on road parcours: AUDI A4 (AUDI Inc., Ingolstadt/FRG) with digital display, with externally controllable head up display (HUD, VW AG, Wolfsburg/FRG)) for presentation of LANDOLT Cs with varying contrast levels and equipped with dual brake (VEIGEL GmbH + Co KG, Künzelsau/FRG)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refractive media opacities: present | – | –Refractive media opacities: present |
| Refractive media opacities: absent | – | Diagnostic Test: Slit lamp (LOCS III Score)Refractive media opacities: absent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ophthalmologically healthy subjects and patients with incipient to intermediate cataract.
Key inclusion criteria (6 listed)
- age ≥ 18 years (preferred: age, exceeding 50 yrs.)
- Minimum distant visual acuity (with habitual correction) 0.8 (16/20, single optotypes, LANDOLT C chart for presentation of high contrast optotypes according to DIN 58220 - Part 3/ISO 10938 (Visus GmbH, Stuttgart/Germany)
- ametropia maximum spherical ametropia sph ±8.00 dpt maximum maximum astigmatism cyl 2.00 dpt
- normal (age-corrected) visual field
- clear refractive media OR incipient to intermediate cataract
Key exclusion criteria (21 listed)
- epilepsy / psychiatric disorders
- drugs, interfering with reaction time and/or with visual acuity or with refractive status of the eye
- deficient driving license
- yearly mileage less than 3000 km/y (less than 1.864 miles/y)
- ophthalmological exclusion criteria: all ophthalmological diseases or abnormalities, with the exception of those, listed in the above-mentioned inclusion criteria
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 |
|---|---|---|
| Slit lamp (LOCS III Score)Also: Oculus Pentacam (Scheimpflug procedure, densitometry)Diagnostic procedure only | Diagnostic test | Refractive media opacities: absent |
Primary outcome
Pass/fail rate (i.e. ratio of "no. of subjects passed" by "total no. of participants") with respect to a vision-related driving ability test
Time frame: From date of "first subject in" to date of "last subject out", i.e. over an 18 months period
Pass/fail rates will be assessed for vision related driving ability tests: (i) clinical photopic/mesopic contrast vision tests, (ii) glare tests, (iii) of driving simulator tests under mesopic conditions with and without glare, and (iv) on-road tests under mesopic conditions with and without glare
4 secondary outcomes
Rank of tested subjects with respect to a vision-related driving ability test
Time frame: From date of "first subject in" to date of "last subject out", i.e. over an 18 months period
Test-retest reliability, expressed as "limits of agreement" (LOA) of a clinical contrast vision test
Time frame: From date of "first subject in" to date of "last subject out", i.e. over an 18 months period
Response time (in milliseconds) regarding to the gap recognition of a standardized optotype
Time frame: From date of "first subject in" to date of "last subject out", i.e. over an 18 months period
Intensity of driving simulator sickness, assessed by a questionnaire
Time frame: From date of "first subject in" to date of "last subject out", i.e. over an 18 months period
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 10 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Ulrich Schiefer, Prof. Dr. principal investigator
Aalen University of Applied Sciences
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 Cataract and Traffic Accident, 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 6 inclusion and 21 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 10 Jan 2019. 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?
Pass/fail rate (i.e. ratio of "no. of subjects passed" by "total no. of participants") with respect to a vision-related driving ability test (time frame: From date of "first subject in" to date of "last subject out", i.e. over an 18 months period). 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 10 Jan 2019.