HealthyNCT02177669
Test-Retest Variability of Quick Contrast Sensitivity Function Testing
An observational study of Healthy, run by Nova Southeastern University at 1 site in United States.
Trial summary
The contrast sensitivity function (CSF) provides a comprehensive characterization of spatial vision and predicts functional vision better than visual acuity, but long testing times prevent its psychophysical assessment in clinical applications. Dr. Luis Lesmes et al. Read more about this study
- Who is it for?
- Ages 20 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- quick Contrast Sensitivity Function test
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Nov 2016
- 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 20 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals between the ages of 20-89 without ocular disease will be recruited from among patients seen in the Primary Eye Care Clinic at the Nova Southeastern University's The Eye Care Institute in Davie-Ft. Lauderdale, FL, as well as faculty, students and staff at this institution.
Who may be able to join
- Ages 20-89
- Normal distance visual acuity in each of both eyes (20/20)
- Absence of ocular disease
- Able and willing to complete contrast sensitivity testing
- Provide informed consent
Who cannot join
- Any ocular disease
- Refractive errors >6D
- Inability to understand study or communicate responses (cognitive impairment)
- Unable to understand, read and speak English fluently
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University; College of Optometry
Fort Lauderdale, Florida, 33328
About this study
The contrast sensitivity function (CSF) provides a comprehensive characterization of spatial vision and predicts functional vision better than visual acuity, but long testing times prevent its psychophysical assessment in clinical applications. Dr. Luis Lesmes et al. (2010) developed the qCSF method to obtain precise CSF measurements in only 30-50 trials using a computerized software program that presents letters on a large monitor that are identified by a patient similar to typical visual acuity testing with an eye chart. The quick CSF method is a Bayesian adaptive method that estimates the full shape of the CSF, and the test duration is only about 3-6 minutes. Some preliminary testing has been performed at other sites with this test in patients with vision loss due to amblyopia and glaucoma, but data from individuals without eye disease who have normal visual acuity has not been systematically collected with the latest version of this test procedure across a wide range of ages. In addition, we aim to gain a better understanding of the typical test-retest variability that is obtained between-sessions that are about a week apart from individuals with good ocular health and visual acuity.
- Conditions
- Healthy
- Being tested
- quick Contrast Sensitivity Function test
- Keywords
- Normal, healthy individuals without ocular disease, Ages 20-89, English speaking, Visual acuity better than 20/25
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quick Contrast Sensitivity Function testOther
| Study group | Role | What they receive |
|---|---|---|
| Normals without ocular disease | Not described Receives: Other: quick Contrast Sensitivity Function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
95% coefficient of repeatability across subjects
We will evaluate various contrast sensitivity metrics that are generated by the computer program: (i) AULCSF or area under the curve for the log contrast sensitivity function (CSF), (ii) CSF acuity or the cutoff-frequency at which sensitivity=2.0 is calculated, and (iii) contrast sensitivity at various spatial frequencies (i.e. 1.5, 3, 6, 12, 18.5 cycles per degree), obtained with testing performed binocularly, with the better eye monocularly, and with the better eye using a NoIR 4% transmission filter. Within subject, the data will be analyzed as differences between the two values obtained at the two sessions, which can then be used to determine a 95% coefficient of repeatability across subjects.
Measured: test-retest at 2 visits about a week apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Adaptive Sensory Technology
- Responsible party
- Sponsor
- Investigators
- Ava K Bittner, OD, PhD, Principal investigator, Nova Southeastern University; College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177669
- Sponsor's protocol ID
- 05291468Exp
- Other IDs
- R21EY023720, Adaptive Sensory Technology
- Status last verified
- Apr 2017
- First submitted
- 26 Jun 2014
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dorr M, Lesmes LA, Lu ZL, Bex PJ. Rapid and reliable assessment of the contrast sensitivity function on an iPad. Invest Ophthalmol Vis Sci. 2013 Nov 5;54(12):7266-73. doi: 10.1167/iovs.13-11743.
PubMed 24114545Lesmes LA, Lu ZL, Baek J, Albright TD. Bayesian adaptive estimation of the contrast sensitivity function: the quick CSF method. J Vis. 2010 Mar 30;10(3):17.1-21. doi: 10.1167/10.3.17.
PubMed 20377294
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-Retest Variability of Quick Contrast Sensitivity Function Testing
- ClinicalTrials.gov ID
- NCT02177669
- Acronym / sponsor ID
- 05291468Exp
- Conditions
- Healthy
- Keywords
- Normal, healthy individuals without ocular disease, Ages 20-89, English speaking, Visual acuity better than 20/25
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- Adaptive Sensory Technology
- Study start
- Jun 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Jun 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.
The contrast sensitivity function (CSF) provides a comprehensive characterization of spatial vision and predicts functional vision better than visual acuity, but long testing times prevent its psychophysical assessment in clinical applications. Dr. Luis Lesmes et al. (2010) developed the qCSF method to obtain precise CSF measurements in only 30-50 trials using a computerized software program that presents letters on a large monitor that are identified by a patient similar to typical visual acuity testing with an eye chart. The quick CSF method is a Bayesian adaptive method that estimates the full shape of the CSF, and the test duration is only about 3-6 minutes. Some preliminary testing has been performed at other sites with this test in patients with vision loss due to amblyopia and glaucoma, but data from individuals without eye disease who have normal visual acuity has not been systematically collected with the latest version of this test procedure across a wide range of ages. In addition, we aim to gain a better understanding of the typical test-retest variability that is obtained between-sessions that are about a week apart from individuals with good ocular health and visual acuity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normals without ocular disease | – | Other: quick Contrast Sensitivity Function test |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals between the ages of 20-89 without ocular disease will be recruited from among patients seen in the Primary Eye Care Clinic at the Nova Southeastern University's The Eye Care Institute in Davie-Ft. Lauderdale, FL, as well as faculty, students and staff at this institution.
Key inclusion criteria (5 listed)
- Ages 20-89
- Normal distance visual acuity in each of both eyes (20/20)
- Absence of ocular disease
- Able and willing to complete contrast sensitivity testing
- Provide informed consent
Key exclusion criteria (4 listed)
- Any ocular disease
- Refractive errors >6D
- Inability to understand study or communicate responses (cognitive impairment)
- Unable to understand, read and speak English fluently
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 |
|---|---|---|
| quick Contrast Sensitivity Function test | Other | Normals without ocular disease |
Primary outcome
95% coefficient of repeatability across subjects
Time frame: test-retest at 2 visits about a week apart
We will evaluate various contrast sensitivity metrics that are generated by the computer program: (i) AULCSF or area under the curve for the log contrast sensitivity function (CSF), (ii) CSF acuity or the cutoff-frequency at which sensitivity=2.0 is calculated, and (iii) contrast sensitivity at various spatial frequencies (i.e. 1.5, 3, 6, 12, 18.5 cycles per degree), obtained with testing performed binocularly, with the better eye monocularly, and with the better eye using a NoIR 4% transmission filter. Within subject, the data will be analyzed as differences between the two values obtained at the two sessions, which can then be used to determine a 95% coefficient of repeatability across subjects.
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 11 Apr 2017.
- Background: PubMed 24114545Dorr M, Lesmes LA, Lu ZL, Bex PJ. Rapid and reliable assessment of the contrast sensitivity function on an iPad. Invest Ophthalmol Vis Sci. 2013 Nov 5;54(12):7266-73. doi: 10.1167/iovs.13-11743.
- Background: PubMed 20377294Lesmes LA, Lu ZL, Baek J, Albright TD. Bayesian adaptive estimation of the contrast sensitivity function: the quick CSF method. J Vis. 2010 Mar 30;10(3):17.1-21. doi: 10.1167/10.3.17.
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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.
Ava K Bittner, OD, PhD principal investigator
Nova Southeastern University; College of Optometry
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 Healthy, run by Nova Southeastern University at 1 site in United States.
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 4 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 11 Apr 2017. 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 United States. 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?
95% coefficient of repeatability across subjects (time frame: test-retest at 2 visits about a week apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02177669, which also lists 2 linked publications.
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 Apr 2017.