Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO



Status:Completed
Conditions:Cardiology, Ocular, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Ophthalmology
Healthy:No
Age Range:21 - Any
Updated:4/21/2016
Start Date:October 2012
End Date:November 2012

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To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO.
The study will assess variability across measurements taken by three different
operator-device configuration across clinical sites, variability between subjects within a
given operator-device configuration, and variability within a subject for a single
operator-device configuration.


Inclusion Criteria:

- Subject must be 21 years of age or older.

- Subjects recruited to Cohort 1 will have no known retinal disease except for
refractive errors (-7.5 D to +7.5 diopters).Subjects who are recruited to Cohort 2
will have one or more of the following retinal pathologies: early and intermediate
Age-Related Macular Degeneration, Geographic Atrophy, Diabetic Retinopathy (mild,
moderate, severe), Macular Edema secondary to Diabetes, Retinal Vein Occlusion,
Central Serous Retinopathy, Pattern Dystrophy, Epiretinal Membrane or Macular Hole.

- Subjects who have signed an informed consent form.

- Subjects who can comply with the protocol.

Exclusion Criteria:

- Subjects younger than 21 years of age.

- Subjects who cannot comply with the protocol.

- Subjects who cannot complete the Simple Test procedures

- Subjects who are not available to be testing 3 times during the day (Morning, Mid -
Day, and Afternoon).

- Subjects with visual acuity worse than 20/100 (Best Corrected).

- Subjects with dense media opacities.

- Ocular surgery anticipated on the day of the study visit.
We found this trial at
3
sites
Fort Lauderdale, Florida 33334
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Baltimore, Maryland
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Baltimore, MD
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McAllen, Texas 78503
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McAllen, TX
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