Diabetic Retinopathy Clinical Trial
Official title:
RETeval Calibration / Validation Study - Diabetic Retinopathy
RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy. The purpose of this study is to calibrate RETeval, and then measure its ability to detect vision threatening diabetic retinopathy. Early Treatment Diabetic Retinopathy Study (ETDRS) 7-field, dilated, stereo, color fundus photography, read according to the ETDRS protocol, will be used as the gold standard.
Diabetic retinopathy is the leading cause of preventable blindness in working age Americans.
The associated loss of quality of life, and the economic loss from health care costs and
lost productivity, are staggering. This burden is increasing rapidly as the epidemic of
diabetes continues. In the developing world, diabetic retinopathy is expected to become the
leading cause of preventable blindness since the prevalence of diabetes correlates closely
with the dietary changes, obesity, and sedentary lifestyles that accompany economic
development.
Half of all people with proliferative diabetic retinopathy will be blind within five years.
With proven laser and intravitreal drug therapy this risk is reduced to less than 5%, a
ten-fold decrease in risk. One third of all people with diabetic macular edema will suffer
moderate visual loss in three years. With proven therapy this risk is reduced to less than
10%, a three-fold decrease in risk. Nonetheless, diabetic retinopathy remains the leading
cause of preventable blindness in working age Americans.
Excellent diabetes control prevents or significantly reduces the development and progression
of diabetic retinopathy but this approach requires difficult lifestyle changes. Therefore,
timely identification of patients at risk for blindness, and assuring they receive proven
care, are essential to eliminate blindness from diabetic retinopathy. Unfortunately, despite
decades of public health awareness campaigns and programs, only 56.9% of US patients with
diabetes received universally recommended eye evaluations in 2011.
One reason for this failure is the complexity of existing methods for diabetic retinopathy
testing. To be effective, accurate testing should be available in the primary care
physician's office since the need for an additional visit to an ophthalmologist is another
reason universal testing has failed. To succeed in the primary care physician's office,
existing personnel, with minimal training, must be able to accurately and easily test
patients. The testing method must take little time and require no additional space since
efficient time and space utilization are critical in primary care settings. It must meet
quality measures used by Medicare and other payors to award financial incentives. Finally,
it must be reimbursed at a favorable level.
RETeval is LKC Technologies' new, handheld, non-invasive, device that measures full-field
ERG cone b-wave photopic flicker implicit times quickly and easily in a primary care
setting. RETeval is simple to use and takes less than five minutes for most patients. It is
a handheld device that requires no additional space. Based on published literature, the
implicit time is significantly delayed in eyes with severe non proliferative diabetic
retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) relative to eyes with milder
forms of DR. These findings suggest that the photopic ERG implicit time can be a good
indicator for the objective evaluation of the severity of DR ranging from mild NPDR to PDR.
This study will measure the accuracy of the RETeval device. ETDRS 7-field, dilated, stereo,
color fundus photography, read according to the ETDRS protocol, will be used as the gold
standard. Cone b-wave photopic flicker implicit time, measured by the RETeval device, and
ETDRS photography, will be performed during a single visit. A random sample of the results,
the calibration set, will be used to calibrate the referral threshold for the RETeval
device. The remaining results, the validation set, will be used as an independent validation
to assess accuracy. If RETeval is accurate, and is accepted as a quality measure meeting
performance standards, it will be an ideal method to test for retinopathy in patients with
diabetes.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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