NCT02177669

Brief 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. (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

June 26, 2014

Last Update Submit

April 10, 2017

Conditions

Keywords

Normal, healthy individuals without ocular diseaseAges 20-89English speakingVisual acuity better than 20/25

Outcome Measures

Primary Outcomes (1)

  • 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.

    test-retest at 2 visits about a week apart

Study Arms (1)

Normals without ocular disease

Other: quick Contrast Sensitivity Function test

Interventions

Normals without ocular disease

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Any ocular disease
  • Refractive errors \>6D
  • Inability to understand study or communicate responses (cognitive impairment)
  • Unable to understand, read and speak English fluently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University; College of Optometry

Fort Lauderdale, Florida, 33328, United States

Location

Related Publications (2)

  • 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.

    PMID: 24114545BACKGROUND
  • 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.

    PMID: 20377294BACKGROUND

Study Officials

  • Ava K Bittner, OD, PhD

    Nova Southeastern University; College of Optometry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2014

First Posted

June 30, 2014

Study Start

June 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations