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Temporal Variation in Optical Coherence Tomography
Measurements of Retinal Thickening in Diabetic Macular Edema
Protocol
Status: Completed
"Click here to view protocol"
A.
Study Design
- Multi-center observational
study.
- The study will take place on
a single day from about 7:30 a.m. to 4:30 p.m.
B.
Objectives
- Determine the proportion of
eyes that demonstrate a potentially meaningful change in central retinal
thickening measured on OCT throughout the day.
- Establish the time course of
change for the eyes that experience diurnal change in central retinal
thickening.
- Evaluate intra-observer and
inter-observer variability on OCT measurements.
C.
Major Eligibility Criteria
- In at least one eye:
- Definite retinal thickening
due to diabetic macular edema based on clinical exam involving the
center of the macula.
- OCT central subfield
>=225 microns.
D.
Sample Size:
100 patients.
E.
Schedule of Testing Times and Examination Procedures
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8 AM
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9 AM
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10 AM
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12 PM* (noon)
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2 PM
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4 PM
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OCT OU
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X
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X
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X
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X
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X
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X
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ETDRS
refraction
and visual acuity OU
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X
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X
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X
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Blood
pressure
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X
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X
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X
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Blood
Glucose
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X
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X
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X
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*Prior to eating lunch
Time window: The procedures should be
performed within 30 minutes of each time point.
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