- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02177669
Test-Retest Variability of Quick Contrast Sensitivity Function Testing
April 10, 2017 updated by: Nova Southeastern University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Fort Lauderdale, Florida, United States, 33328
- Nova Southeastern University; College of Optometry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Any ocular disease
- Refractive errors >6D
- Inability to understand study or communicate responses (cognitive impairment)
- Unable to understand, read and speak English fluently
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Normals without ocular disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
test-retest at 2 visits about a week apart
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ava K Bittner, OD, PhD, Nova Southeastern University; College of Optometry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Lesmes 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
June 26, 2014
First Submitted That Met QC Criteria
June 27, 2014
First Posted (Estimate)
June 30, 2014
Study Record Updates
Last Update Posted (Actual)
April 11, 2017
Last Update Submitted That Met QC Criteria
April 10, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 05291468Exp
- R21EY023720 (U.S. NIH Grant/Contract)
- Adaptive Sensory Technology (Other Grant/Funding Number: Adaptive Sensory Technology)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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