Methods to Measure Contrast VisionNCT02767284
A Comparative Study of Six Methods to Measure Human Contrast Vision
A study testing UCST-V1, UCST-V2 and UCST-V3 in people with Methods to Measure Contrast Vision, run by Uppsala University at 1 site in Sweden.
Trial summary
This study evaluates the relative performance of different methods to measure the human spectral contrast sensitivity function (CSF). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Methods to Measure Contrast Vision
- What is being tested?
- UCST-V1, UCST-V2 and UCST-V3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2016to Oct 2017
- Phase
- Interventional
- 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
Who may be able to join
- Normal best corrected visual acuity: LogMAR = 0
- No current or previous eye disease in either eye.
- Student at Uppsala University
Who cannot join
- Previous surgery in any eye
- Inability to follow the test procedure.
Trial locations and contacts
1 site in 1 country.
Gunneli Ekberg contact
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, 75185
About this study
Official title: UCST Studie 1 - Jämförande Studie Mellan några Befintliga Och Nyutvecklade Metoder för Att mäta Den Spektrala kontrastkänslighetsfunktionen Hos människa
This study evaluates the relative performance of different methods to measure the human spectral contrast sensitivity function (CSF).
Read the detailed description
The human spectral contrast sensitivity function (CSF) is a better way to estimate human vision than letter charts commonly used by ophthalmologists, optometrists and opticians.
The current methods used to measure the CSF are often unreliable, due to high variability between measurements. This study will compare four (4) new tests with two (2) currently used standard tests. The contrast sensitivity function will be measured using all of the six (6) methods three times (3) in each of the two (2) eyes at two (2) occasions. Each subjects CSF will be measured 6x3x2x2 = 72 times.
In addition, for each of the CSF measurements, the time used to measure the CSF and number of background variables for the subjects will be recorded.
After informed consent is obtained, the subjects will undergo a visual examination. If they match the inclusion criteria they will be included. At that time or at their earliest possible convenience, their CSF will be measured using the six methods and some background information will be recorded.
The follow-up measurement occasion will occur between 4 to 6 weeks (28 to 42 days) after the first.
To facilitate comparison with previous studies, the CSF-measurements (in rel. contrast/cycles/degree) will be converted to a log (Base 10 logarithm) scale. The unit will thus be log CSF (LCSF) [log[relative contrast]/log[cycles/per degree]].
- Conditions
- Methods to Measure Contrast Vision
- Being tested
- UCST-V1, UCST-V2, UCST-V3, Quick-CSF (QCSF), Pelli-Robson
- Keywords
- Contrast Sensitivity, Diagnostic Techniques, Ophthalmological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCST-V1Device
A previously developed device, Uppsala Contrast Sensitivity Tester - UCST-V1, that quickly measures the human CSF in one stimulus.
UCST-V2Device
A refined version of the UCST-V1 that randomizes frequency order.
UCST-V3Device
A version that utilises eye-tracking technology to make the measurements more accurate.
Quick-CSF (QCSF)Device
A fast contrast sensitivity measurement method using a Bayesian algorithm.
Pelli-RobsonDevice
A standard method developed using a Sloan-letter chart with decreasing contrast.
Optec 6500Device
A standard test using sinusoidal gratings to measure the contrast sensitivity function.
| Study group | Role | What they receive |
|---|---|---|
| UCST-V1 | Experimental | The UCST-V1 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover) Receives: Device: UCST-V1 |
| UCST-V2 | Experimental | The UCST-V2 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover) Receives: Device: UCST-V2 |
| UCST-V3 | Experimental | The UCST-V3 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover) Receives: Device: UCST-V3 |
| Quick-CSF | Experimental | The Quick-CSF test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover) Receives: Device: Quick-CSF (QCSF) |
| Pelli-Robson | Active comparator | The Pelli-Robson contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover) Receives: Device: Pelli-Robson |
| Optec 6500 | Active comparator | The Optec 6500 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover) Receives: Device: Optec 6500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average time (in seconds) used to measure the contrast sensitivity function for one eye for each method
Measured: At end of data collection (up to 12 months after first subject is included)
Average area under the curve for the log contrast sensitivity function (AULCSF) in one eye for each method
The area-under-curve of the LCSF, calculated from the measured CSF.
Measured: At end of data collection (up to 12 months after first subject is included)
Secondary outcomes (2)
Sources of variability of the average time used to measure the contrast sensitivity function [seconds squared]
The factors occasion, eye, acuity, measurement order, sex,examiner will used in an ANOVA
Measured: At end of data collection (up to 12 months after first subject is included)
Sources of variability of the average area under the curve for the log contrast sensitivity function [AULCSF squared]
The factors occasion, eye, acuity, measurement order, sex,examiner will used in an ANOVA
Measured: At end of data collection (up to 12 months after first subject is included)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methods to Measure Contrast VisionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. Per Söderberg, M.D PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767284
- Sponsor's protocol ID
- UCST-01.2014
- Status last verified
- Jun 2016
- First submitted
- 4 May 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymous or pseudo-anonymous data will be available on request or in a repository.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UCST Studie 1 - Jämförande Studie Mellan några Befintliga Och Nyutvecklade Metoder för Att mäta Den Spektrala kontrastkänslighetsfunktionen Hos människa
- ClinicalTrials.gov ID
- NCT02767284
- Acronym / sponsor ID
- UCST-01.2014
- Conditions
- Methods to Measure Contrast Vision
- Keywords
- Contrast Sensitivity, Diagnostic Techniques, Ophthalmological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 10 May 2016 (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.
This study evaluates the relative performance of different methods to measure the human spectral contrast sensitivity function (CSF).
Detailed description
The human spectral contrast sensitivity function (CSF) is a better way to estimate human vision than letter charts commonly used by ophthalmologists, optometrists and opticians.
The current methods used to measure the CSF are often unreliable, due to high variability between measurements. This study will compare four (4) new tests with two (2) currently used standard tests. The contrast sensitivity function will be measured using all of the six (6) methods three times (3) in each of the two (2) eyes at two (2) occasions. Each subjects CSF will be measured 6x3x2x2 = 72 times.
In addition, for each of the CSF measurements, the time used to measure the CSF and number of background variables for the subjects will be recorded.
After informed consent is obtained, the subjects will undergo a visual examination. If they match the inclusion criteria they will be included. At that time or at their earliest possible convenience, their CSF will be measured using the six methods and some background information will be recorded.
The follow-up measurement occasion will occur between 4 to 6 weeks (28 to 42 days) after the first.
To facilitate comparison with previous studies, the CSF-measurements (in rel. contrast/cycles/degree) will be converted to a log (Base 10 logarithm) scale. The unit will thus be log CSF (LCSF) [log[relative contrast]/log[cycles/per degree]].
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| UCST-V1 | Experimental | Device: UCST-V1The UCST-V1 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover) |
| UCST-V2 | Experimental | Device: UCST-V2The UCST-V2 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover) |
| UCST-V3 | Experimental | Device: UCST-V3The UCST-V3 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover) |
| Quick-CSF | Experimental | Device: Quick-CSF (QCSF)The Quick-CSF test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover) |
| Pelli-Robson | Active comparator | Device: Pelli-RobsonThe Pelli-Robson contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover) |
| Optec 6500 | Active comparator | Device: Optec 6500The Optec 6500 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal best corrected visual acuity: LogMAR = 0
- No current or previous eye disease in either eye.
- Student at Uppsala University
Key exclusion criteria (2 listed)
- Previous surgery in any eye
- Inability to follow the test procedure.
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 |
|---|---|---|
| UCST-V1A previously developed device, Uppsala Contrast Sensitivity Tester - UCST-V1, that quickly measures the human CSF in one stimulus. | Device | UCST-V1 |
| UCST-V2A refined version of the UCST-V1 that randomizes frequency order. | Device | UCST-V2 |
| UCST-V3A version that utilises eye-tracking technology to make the measurements more accurate. | Device | UCST-V3 |
| Quick-CSF (QCSF)A fast contrast sensitivity measurement method using a Bayesian algorithm. | Device | Quick-CSF |
| Pelli-RobsonA standard method developed using a Sloan-letter chart with decreasing contrast. | Device | Pelli-Robson |
| Optec 6500A standard test using sinusoidal gratings to measure the contrast sensitivity function. | Device | Optec 6500 |
Primary outcome
Average time (in seconds) used to measure the contrast sensitivity function for one eye for each method
Time frame: At end of data collection (up to 12 months after first subject is included)
Average area under the curve for the log contrast sensitivity function (AULCSF) in one eye for each method
Time frame: At end of data collection (up to 12 months after first subject is included)
The area-under-curve of the LCSF, calculated from the measured CSF.
2 secondary outcomes
Sources of variability of the average time used to measure the contrast sensitivity function [seconds squared]
Time frame: At end of data collection (up to 12 months after first subject is included)
Sources of variability of the average area under the curve for the log contrast sensitivity function [AULCSF squared]
Time frame: At end of data collection (up to 12 months after first subject is included)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Individual participant dataSharing planned: Yes. Anonymous or pseudo-anonymous data will be available on request or in a repository.
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.
Gunneli Ekberg contact
Prof. Per Söderberg, M.D PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UCST-V1, UCST-V2 and UCST-V3 in people with Methods to Measure Contrast Vision, run by Uppsala University at 1 site in Sweden.
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 3 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 28 Jun 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 Sweden. 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 Lars Malmqvist, M.D (+46186115135, lars.malmqvist@neuro.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average time (in seconds) used to measure the contrast sensitivity function for one eye for each method (time frame: At end of data collection (up to 12 months after first subject is included)). 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 28 Jun 2016.