Performance assessment testing may be a useful tool to evaluate the impact of ranibizumab on day-to-day visual function in patients with Diabetic Macular Edema (DME).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
California Retina Consultants - Bakersfield
Bakersfield, California, United States
California Retina Consultants
Oxnard, California, United States
California Retina Consultants
Palmdale, California, United States
California Retina Consultants - Santa Barbara Office
Santa Barbara, California, United States
A Change Between Two Time Points is Reported for Maximum Reading Speed
A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed.
Time frame: Month 12
Change in Activity Productivity
To evaluate the mean change in activity impairment from baseline to 12 months using and activity impairment questionnaire. Scale is from 0-10 with 0 being lowest (no effect on my daily activities) and 10 being highest (completely prevented me from doing my daily activities).
Time frame: Month 12
Change in Visual Acuity
To determine the mean change in best-corrected visual acuity on ETDRS visual acuity chart at a starting distance of 4 meters from baseline. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.
Time frame: Month 12
Change in Contrast Sensitivity
To measure the mean change in contrast sensitivity scores on Pelli-Robson charts from baseline. Scale in assessing the log of the contract sensitivity score (CS score) is from 0-2.25, with 0 being no letters read on the contrast sensitivity chart, and 2.25 being all letters read on the contrast sensitivity chart. Total CS score = \[(total # letters correct - 3) x 0.05\].
Time frame: 12 months
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California Retina Consultants
Santa Maria, California, United States
California Retina Consultants
Visalia, California, United States