Ophthalmologically Normal SubjectsFELNCT02198534
Comparison of the Freiburg Visual Acuity Test (FrACT) With the EDTRS- and Landoltring Charts
An observational study of Ophthalmologically Normal Subjects, run by Schiefer Ulrich at 1 site in Germany.
Trial summary
A) For the investigation of Visual acuity, inter-test agreement and the test-retest reliability were used three different visual acuity tests: ETDRS charts, Landoltring chart and Freiburg Visual Acuity Test (FrACt). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ophthalmologically Normal Subjects
- What is being tested?
- Methodology of visual acuity assessment
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Jun 2015
- 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 normal subjects
Who may be able to join
- age ≥ 18 years
- Minimum distant visual acuity (without/with correction) 0.2 (Visucat, single letter optotypes [numbers], initial session). As long as minimum distant visual acuity limits are exceeded, test runs without optical corrections are preferred in order to enhance the spectrum/variety of tested visual acuity values
- Ametropia:
- maximum myopia sph -2.00 dpt maximum hyperopia sph +5.50 dpt maximum astigmatism cyl 2.5 dpt
- informed consent
Who cannot join
- Epilepsy / psychiatric disorders
- Drugs affect the reaction time and / or determining the visual acuity, or the refractive power of the eye
- Ophthalmic Education
- Amblyopia
- strabismus
- Glaucoma IOP> 22 mmHg
Show all 16Show fewer
- Nystagmus
- Diabetic retinopathy (blood sugar-related retinal disease)
- Very dry eyes (sicca symptoms)
- eye surgery back are less than 3 months
- Infectious diseases (conjunctivitis, corneal inflammation, choroidal inflammation)
- miosis drugs
- Pronounced eye injuries
- Other eye disorders that affect the image quality
- Macular diseases
- albinism
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: Comparison of the Freiburg Visual Acuity Test (FrACT) With the EDTRS- and Landoltring Charts: a) Assessment of the Inter-test Agreement and the Test-retest Reliability b) Analysis of Examinees' / Examiner's Subjective Rating and of Test Durations
- For the investigation of Visual acuity, inter-test agreement and the test-retest reliability were used three different visual acuity tests: ETDRS charts, Landoltring chart and Freiburg Visual Acuity Test (FrACt). The examinees passed each visual acuity test twice but the sequence of the visual acuity tests were randomize and so different for each examinee. The examinees were 24 adult Aalen university students (except students of ophthalmic optics in terms 2 - 7) with a minimal distant visual acuity without or with correction of 0.2. Another inclusion criteria was a maximum myopia of sph -2,00 dpt, a maximum hyperopia of sph +5,50 dpt and a maximum astigmatism of cyl 2,50 dpt. The Landolt C was projected in eight-orientations. For the FrACT Test we used two different devices for response input: a modified keypad with Landoltring symbols (FrACTk) and a haptic Landolt device with an adjustable Landoltring (FrACTh). The primary objective was the comparison between FrACTk and FrACTh. The secondary Objective contains the comparison between all visual acuity tests.
- Background: Landolt Cs and letters are commonly used optotypes. In the explorative study we compare four different ways of applying them: The Freiburg visual acuity test (FrACT) using a keypad and a haptic Landolt device, a Landolt C chart in accordance to ISO 8596 and DIN 58220 with eight-orientated Landolt C and ETDRS charts. The aims of the survey were to determine examinee´s/examiner´s subjective ratings using Visual analogue scales (VAS), the inter-test agreement between the tests and test-retest reliability of the tests, concerning the test duration.
Subjects and Methods: Twenty-four adult examinees with a visual acuity of ≥ 0,2 were included in the explorative study. The visual acuity of one eye was measured monocularly, randomized with regard to the leading/non-leading eye. The subjects passed every visual acuity test twice in a randomized sequence of the visual acuity tests, which is maintained by a pre-specified randomization list, making use of forced choice.
Read the detailed description
- FrACT (internet version 3.8.1) 1.1 haptic Landolt Ring device (FrACTh) 1.2 modified keypad with Landolt Ring symbols (FrACTk)
- ETDRS Visual Acuity Tester (Steinbeis Transferzentrum Biomedizinische Optik, Tübingen/Germany)
- Landoltring chart (Visus GmbH, Stuttgart/Germany)
- VISUCAT monitor with single optotype display(numbers; Argus Individuell Optic GmbG, Putzbrunn/Germany)
- Room illuminance level 250 lx, assessed with digital luxmeter (Peak Tech 5025, Peak Tech Prüf - und Messtechnik GmbH, Ahrensburg/Germany)
- Laptopdisplay (TravelMate, Acer, 8372 Taipeh/China): luminance level 151 cd/m2 , surround luminance level 75 cd/m2 , assessed with luminance meter (IS-110 Laptop Minolta, Tokyo/Japan)
- ETDRS Visual Acuity Tester: luminance level: 237 cd/m², surround luminance level 85 cd/m²
- Landoltring Chart: luminance level: 236 cd/m², surround luminance level 84 cd/m²
- VISUCAT: luminance level: 380 cd/m², surround luminance level 70 cd/m²
- Stopwatch (Apple iPhone 4S, Cupertino CA/USA)
- Laser Rangefinder (GLM 80 Professional, Bosch GmbH, Stuttgart/Germany)
- Conditions
- Ophthalmologically Normal Subjects
- Being tested
- Methodology of visual acuity assessment
- Keywords
- visual acuity, Landolt C, ETDRS charts, Freiburg Visual Acuity Test, FrACT, Comparison, acceptance, Test retest reliability, duration, questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methodology of visual acuity assessmentDevice
Also called VISUCAT, FrACT, ETDRS Chart, Landolt C
| Study group | Role | What they receive |
|---|---|---|
| ophthalomogically normal subjects | Not described Receives: Device: Methodology of visual acuity assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
A) 1.Visual acuity (in terms of spatial resolution)
Comparison of visual acuity measurements, visualized by Bland-Altman plots
Measured: July - August, 2014 (1 month)
Inter-test agreement between FrACTh and FrACTk with regard to visual acuity results
Assessment of inter-test agreement between FrACTh and FrACTk by comparison between these two methods, visualized by Bland-Altman plots
Measured: July - August, 2014 (1 month)
Test-retest reliability of FrACTh and FrACTk with regard to visual acuity results
Assessment of test-retest reliability of FrACTh and FrACTk by repeated measurements, visualized by Bland-Altman plots
Measured: July - August, 2014 (1 month)
Secondary outcomes (2)
Examinees´ / examer's subjective ratings regarding the test procedures
Assessment of examinees´ / examiner´s subjective ratings, using box \& whisker plots for analysis of the visual analogue scale (VAS) results
Measured: July - August, 2014 (1 month)
Test duration (in seconds)
Assessment of test duration and its comparison, using box \& whisker plots and/or Bland-Altman plots
Measured: July - August, 2014 (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmologically Normal SubjectsStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schiefer Ulrich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Schiefer Ulrich, Aalen University
- Investigators
- Ulrich Schiefer, Prof. Dr. med., Principal investigator, University of Applied Sciences Aalen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198534
- Sponsor's protocol ID
- F-2014-049
- Acronym
- FEL
- Status last verified
- Nov 2016
- First submitted
- 21 Jul 2014
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Freiburg Visual Acuity Test (FrACT) With the EDTRS- and Landoltring Charts: a) Assessment of the Inter-test Agreement and the Test-retest Reliability b) Analysis of Examinees' / Examiner's Subjective Rating and of Test Durations
- ClinicalTrials.gov ID
- NCT02198534
- Acronym / sponsor ID
- FEL / F-2014-049
- Conditions
- Ophthalmologically Normal Subjects
- Keywords
- visual acuity, Landolt C, ETDRS charts, Freiburg Visual Acuity Test, FrACT, Comparison, acceptance, Test retest reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Schiefer UlrichUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Jul 2014 (estimated)
- 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.
- For the investigation of Visual acuity, inter-test agreement and the test-retest reliability were used three different visual acuity tests: ETDRS charts, Landoltring chart and Freiburg Visual Acuity Test (FrACt). The examinees passed each visual acuity test twice but the sequence of the visual acuity tests were randomize and so different for each examinee. The examinees were 24 adult Aalen university students (except students of ophthalmic optics in terms 2 - 7) with a minimal distant visual acuity without or with correction of 0.2. Another inclusion criteria was a maximum myopia of sph -2,00 dpt, a maximum hyperopia of sph +5,50 dpt and a maximum astigmatism of cyl 2,50 dpt. The Landolt C was projected in eight-orientations. For the FrACT Test we used two different devices for response input: a modified keypad with Landoltring symbols (FrACTk) and a haptic Landolt device with an adjustable Landoltring (FrACTh). The primary objective was the comparison between FrACTk and FrACTh. The secondary Objective contains the comparison between all visual acuity tests.
- Background: Landolt Cs and letters are commonly used optotypes. In the explorative study we compare four different ways of applying them: The Freiburg visual acuity test (FrACT) using a keypad and a haptic Landolt device, a Landolt C chart in accordance to ISO 8596 and DIN 58220 with eight-orientated Landolt C and ETDRS charts. The aims of the survey were to determine examinee´s/examiner´s subjective ratings using Visual analogue scales (VAS), the inter-test agreement between the tests and test-retest reliability of the tests, concerning the test duration.
Subjects and Methods: Twenty-four adult examinees with a visual acuity of ≥ 0,2 were included in the explorative study. The visual acuity of one eye was measured monocularly, randomized with regard to the leading/non-leading eye. The subjects passed every visual acuity test twice in a randomized sequence of the visual acuity tests, which is maintained by a pre-specified randomization list, making use of forced choice.
Detailed description
- FrACT (internet version 3.8.1) 1.1 haptic Landolt Ring device (FrACTh) 1.2 modified keypad with Landolt Ring symbols (FrACTk)
- ETDRS Visual Acuity Tester (Steinbeis Transferzentrum Biomedizinische Optik, Tübingen/Germany)
- Landoltring chart (Visus GmbH, Stuttgart/Germany)
- VISUCAT monitor with single optotype display(numbers; Argus Individuell Optic GmbG, Putzbrunn/Germany)
- Room illuminance level 250 lx, assessed with digital luxmeter (Peak Tech 5025, Peak Tech Prüf - und Messtechnik GmbH, Ahrensburg/Germany)
- Laptopdisplay (TravelMate, Acer, 8372 Taipeh/China): luminance level 151 cd/m2 , surround luminance level 75 cd/m2 , assessed with luminance meter (IS-110 Laptop Minolta, Tokyo/Japan)
- ETDRS Visual Acuity Tester: luminance level: 237 cd/m², surround luminance level 85 cd/m²
- Landoltring Chart: luminance level: 236 cd/m², surround luminance level 84 cd/m²
- VISUCAT: luminance level: 380 cd/m², surround luminance level 70 cd/m²
- Stopwatch (Apple iPhone 4S, Cupertino CA/USA)
- Laser Rangefinder (GLM 80 Professional, Bosch GmbH, Stuttgart/Germany)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ophthalomogically normal subjects | – | Device: Methodology of visual acuity assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ophthalmologically normal subjects
Key inclusion criteria (5 listed)
- age ≥ 18 years
- Minimum distant visual acuity (without/with correction) 0.2 (Visucat, single letter optotypes [numbers], initial session). As long as minimum distant visual acuity limits are exceeded, test runs without optical corrections are preferred in order to enhance the spectrum/variety of tested visual acuity values
- Ametropia:
- maximum myopia sph -2.00 dpt maximum hyperopia sph +5.50 dpt maximum astigmatism cyl 2.5 dpt
- informed consent
Key exclusion criteria (16 listed)
- Epilepsy / psychiatric disorders
- Drugs affect the reaction time and / or determining the visual acuity, or the refractive power of the eye
- Ophthalmic Education
- Amblyopia
- 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 |
|---|---|---|
| Methodology of visual acuity assessmentAlso: VISUCAT, FrACT, ETDRS Chart, Landolt C | Device | ophthalomogically normal subjects |
Primary outcome
A) 1.Visual acuity (in terms of spatial resolution)
Time frame: July - August, 2014 (1 month)
Comparison of visual acuity measurements, visualized by Bland-Altman plots
Inter-test agreement between FrACTh and FrACTk with regard to visual acuity results
Time frame: July - August, 2014 (1 month)
Assessment of inter-test agreement between FrACTh and FrACTk by comparison between these two methods, visualized by Bland-Altman plots
Test-retest reliability of FrACTh and FrACTk with regard to visual acuity results
Time frame: July - August, 2014 (1 month)
Assessment of test-retest reliability of FrACTh and FrACTk by repeated measurements, visualized by Bland-Altman plots
2 secondary outcomes
Examinees´ / examer's subjective ratings regarding the test procedures
Time frame: July - August, 2014 (1 month)
Test duration (in seconds)
Time frame: July - August, 2014 (1 month)
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 23 Nov 2016.
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. med. principal investigator
University of Applied Sciences Aalen
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 Ophthalmologically Normal Subjects, run by Schiefer Ulrich 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 16 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 23 Nov 2016. 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?
A) 1.Visual acuity (in terms of spatial resolution) (time frame: July - August, 2014 (1 month)). The study lists 3 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 23 Nov 2016.