Comparison of Visual Acuity Tests.VisCompNCT01312662
Towards Worldwide Comparability of Visual Acuity Assessment
An observational study of Comparison of Visual Acuity Tests. and ETDRS. FrACT. Landolt Rings., run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Purpose of this study is to investigate the agreement, the test-retest reliability of three established and widely used visual acuity tests, to develop a mathematical transformation routine between the results from these three tests, to assess the examinees´ and examiners´ acceptance and to compare the test durations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Comparison of Visual Acuity Tests., ETDRS. FrACT. Landolt Rings.
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to not given
- 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: University eye Hospital Tuebingen
Who may be able to join
- Clinical diagnosis of:
- normal ophthalmological status,
- opacity of the refractive media,
- maculopathy,
- optic neuropathy
- chiasmal and postchiasmal visual pathway pathologies,
- amblyopia (deprivation),
- amblyopia (strabism)
Who cannot join
- underage person
- concomitance of different eye-diseases
Trial locations and contacts
1 site in 1 country.
Felix Tonagel, MD contact
Germany1 site, 1 recruiting
- Recruiting
Institute for Ophthalmic Research, University of Tuebingen
Tübingen, 72076
Felix Tonagel, MD, ResearchGroupVisualPathway@googlemail.com
About this study
Official title: Towards Worldwide Comparability of Visual Acuity Assessment A Pilot Study Comparing ETDRS Visual Acuity Charts, Projected Landolt Charts and the Freiburg Visual Acuity Test (FrACT) With a View to Developing a Mathematical Transformation Routine Between the Results From These Three Tests
Purpose of this study is to investigate the agreement, the test-retest reliability of three established and widely used visual acuity tests, to develop a mathematical transformation routine between the results from these three tests, to assess the examinees´ and examiners´ acceptance and to compare the test durations.
Read the detailed description
Assessment of distant visual acuity is the most frequently used procedure for estimation of visual performance. However, there exist a vast number of markedly differing visual acuity tests worldwide; furthermore there are differing report formats to express acuity. This variety may critically interfere with standardization and comparability of this basic visual test method.
Purpose of this study is to investigate the agreement, the test-retest reliability of three established and widely used visual acuity tests, i.e., the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts, a conventional projected distant visual acuity test according to DIN 58220 part 3, and the Freiburg visual acuity test (FrACT), to develop a mathematical transformation routine between the results from these three tests, to assess the examinees´ and examiners´ acceptance and to compare the test durations.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normal ophthalmological status | Not described | |
| opacity of the refractive media | Not described | |
| maculopathy | Not described | |
| optic neuropathy | Not described | |
| chiasmal and postchiasmal visual pathway pathologies | Not described | |
| amblyopia (deprivation) | Not described | |
| amblyopia (strabism) | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of Visual Acuity Tests.Studies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312662
- Sponsor's protocol ID
- VisComp01
- Acronym
- VisComp
- Status last verified
- Mar 2011
- First submitted
- 8 Mar 2011
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Worldwide Comparability of Visual Acuity Assessment A Pilot Study Comparing ETDRS Visual Acuity Charts, Projected Landolt Charts and the Freiburg Visual Acuity Test (FrACT) With a View to Developing a Mathematical Transformation Routine Between the Results From These Three Tests
- ClinicalTrials.gov ID
- NCT01312662
- Acronym / sponsor ID
- VisComp / VisComp01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University of Freiburg
- Study start
- Mar 2011
- First posted
- 11 Mar 2011 (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.
Purpose of this study is to investigate the agreement, the test-retest reliability of three established and widely used visual acuity tests, to develop a mathematical transformation routine between the results from these three tests, to assess the examinees´ and examiners´ acceptance and to compare the test durations.
Detailed description
Assessment of distant visual acuity is the most frequently used procedure for estimation of visual performance. However, there exist a vast number of markedly differing visual acuity tests worldwide; furthermore there are differing report formats to express acuity. This variety may critically interfere with standardization and comparability of this basic visual test method.
Purpose of this study is to investigate the agreement, the test-retest reliability of three established and widely used visual acuity tests, i.e., the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts, a conventional projected distant visual acuity test according to DIN 58220 part 3, and the Freiburg visual acuity test (FrACT), to develop a mathematical transformation routine between the results from these three tests, to assess the examinees´ and examiners´ acceptance and to compare the test durations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| normal ophthalmological status | – | – |
| opacity of the refractive media | – | – |
| maculopathy | – | – |
| optic neuropathy | – | – |
| chiasmal and postchiasmal visual pathway pathologies | – | – |
| amblyopia (deprivation) | – | – |
| amblyopia (strabism) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- University eye Hospital Tuebingen
Key inclusion criteria (8 listed)
- normal ophthalmological status,
- opacity of the refractive media,
- maculopathy,
- optic neuropathy
- chiasmal and postchiasmal visual pathway pathologies,
Key exclusion criteria (2 listed)
- underage person
- concomitance of different eye-diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
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.
Felix Tonagel, MD contact
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 Comparison of Visual Acuity Tests. and ETDRS. FrACT. Landolt Rings., run by University Hospital Tuebingen 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Mar 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix Tonagel, MD (ResearchGroupVisualPathway@googlemail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 11 Mar 2011.