Building a Database of Results From People Without Eye Problems



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:10 - 90
Updated:4/21/2016
Start Date:August 2012
End Date:August 2015

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A Prospective Study of Controls to Build a Normative Database for the Spaeth/Richman Contrast Sensitivity Test (SPARCS)

The purpose of this study is to build a database of results from a new test that measures
contrast sensitivity (the Spaeth-Richman Contrast Sensitivity Test (SPARCS)). Contrast
sensitivity is an important part of your ability to see. When contrast sensitivity
decreases, you are less able to see objects and detect motion. For instance, if you have
decreased contrast sensitivity, you might be less able to read, see in the dark, drive, hit
a ball, or walk safely. Decrease in contrast sensitivity leads to a decrease in quality of
life.

Objective: To build a normative database for the Spaeth / Richman Contrast Sensitivity Test
(SPARCS).

Background: Patients with glaucoma have diminished contrast sensitivity. SPARCS is a novel
test designed to determine the contrast threshold in the central 5 degrees of vision as well
as each of the 4 peripheral quadrants (superotemporal, superonasal, inferotemporal,
inferonasal). It is performed on a standard computer with at least 1024 x 768 monitor
resolution. The correct testing distance is 50 cm away from the computer screen. Appropriate
refractive correction is used. Testing is performed in a room with standardized lighting (85
cd / m2) and no windows in order to minimize glare and reflections. Testing is performed
monocularly with the non-tested eye covered by an eye patch. The purpose of this study is to
build a normative database for SPARCS.

Study Design: Cross sectional observational study.

Methods: Healthy volunteers will be recruited from the Wills Eye Institute after obtaining
informed consent following the principles of the Helsinki Convention. Approximately 320
people free of ocular disease will be recruited to form a portion of the normative database
for SPARCS. A goal of 20 subjects per decade of life (10-19, 20-29, 30-39, 40-49, 50-59,
60-69, 70-79, 80+) for both Caucasians and African Americans will be recruited. Other
ethnicities will also be recruited, though without specific recruitment goals. Future study
locations will help diversify the population of the normative database.

After agreeing to participate in the study, subjects will be assessed to determine if they
qualify. Potential participants will be asked if they have any known eye diseases or
decreased vision. Best-corrected monocular visual acuities will be assessed using an ETDRS
visual acuity chart. A slit lamp examination will be performed to confirm good ocular
health. Subjects will be excluded if they have any apparent ocular disease that affects
visual acuity or visual function. For example, people with glaucoma, macular degeneration,
or diabetic retinopathy will be excluded. Additional exclusion criteria includes: visual
acuity 20/40 or worse; cataract grade 2 3+ or worse; posterior capsular opacity grade 2 3+
or worse; refractive error greater than +5 or -5 diopters; and incisional eye surgery within
the prior 3 months.

After a person qualifies for the normative database, he or she will then take SPARCS. A
trained technician will position the patient to the correct testing distance, check room
lighting, and then explain the test. Subjects will be told to fixate on the central area and
when ready, click the central area once with a computer mouse. Vertical dark bars will
briefly appear in 1 of the 5 tested areas on the computer monitor. A subject will then move
the mouse to the area the image appeared and click it once. When the subject is ready for
the next image to appear, he or she will click again on the central area. Subjects are also
instructed to guess where the image appeared if unsure. Vertical square waves of varying
contrast levels will then continue to appear in a random pattern until threshold has been
reached for each area. After the testing algorithm has been completed, the test will
automatically end.

Each eye of an eligible subject will take the test twice after receiving instructions from a
technician. The technician will remain in the testing room the first two times SPARCS is
taken. A half hour later, the subject will then take SPARCS again without instructions from
the technician and without the technician being present in the room.

The mean score and standard deviation of each area and the total score will be analyzed for
age, gender, race, and lens status. Spearman correlations will be used to examine continuous
variables and Kruskal-Wallis analysis for categorical measures. Test-retest repeatability
will be assessed using the Coefficient of Repeatability and the Intraclass Correlation
Coefficient.

Inclusion Criteria:

- 10 years or older and healthy

- No eye diseases

Exclusion Criteria:

- Patients with glaucoma, macular degeneration, diabetic retinopathy, corneal disease,
eye movement disorders or any eye disease causing vision loss

- Patients with visual acuity worse than 20/40

- Patients with cataracts or opacities 2+ or greater

- Patients with refractive error +6 -6 or greater
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