Protocol: Temporal Variation in Optical Coherence Tomography Measurements of Retinal Thickening in Diabetic Macular Edema
Status: Closed
Start Date: 10/01/2004
End Date: 05/20/2005
Clinical Trial ID:  
Public Dataset:  Download

 

Temporal Variation in Optical Coherence Tomography Measurements of Retinal Thickening in Diabetic Macular Edema

Protocol Status: Completed

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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

 

8 AM

9 AM

10 AM

12 PM* (noon)

2 PM

4 PM

OCT OU

X

X

X

X

X

X

ETDRS refraction
and visual acuity OU

X

 

 

X

 

X 

Blood pressure

X

 

 

X

 

X 

Blood Glucose

X

 

 

X

 

X 

*Prior to eating lunch

Time window: The procedures should be performed within 30 minutes of each time point.
 


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