FAQ about RetinaRisk™

How is patients’ annualized risk determined? Was the algorithm clinically validated?
The annualized risk is calculated by a proprietary algorithm based upon major, well-established risk factors for the development of sight-threatening diabetic retinopathy. The algorithm has been validated for high predictive accuracy in Icelandic, Danish and Dutch diabetes cohorts.

Is the algorithm applicable to a variety of patient races and ethnicities?
The algorithm has been clinically validated in Northern European diabetes cohorts, which include a variety of races and ethnicities. Our team plans future validation for other populations in the near future. The processes implicated in sight-threatening diabetic retinopathy within all populations are predominantly dependent upon metrics employed by our algorithm, including blood glucose control, blood pressure status, disease duration, gender, diabetes sub-type, and presence or absence of non-proliferative retinopathy.

A number of emerging risk factors for sight-threatening diabetic retinopathy are not part of the clinical data entered into the calculator, including obstructive sleep apnea, obesity, and history of other diabetes complications like non-healing limb ulceration. Why not?
The algorithm accounts for 80% of established risk in patients with diabetes based upon a preponderance of research data, and has been validated for accuracy in large populations of patients with diabetes by accounting for the significant majority of total risk. These emerging factors probably account for 20% of total risk and may very well be important for refinement of predictive power, but require further validation. The personalized report form generated for each patient does, however, allow health care providers to communicate the presence of at least some of these emerging risk factors and recommend additional preventative strategies for patients based upon clinical judgment and new research findings.

If a patients calculated risk of developing sight-threatening retinopathy is low, can that patient safely have less frequent dilated eye examinations?
Decisions about frequency of dilated eye examinations depend upon each practitioner’s clinical judgment, but these decisions should certainly be informed by patient history and clinical findings, as well as calculated risk. There are excellent reasons for routine eye examination other than detection of sight-threatening diabetic retinopathy.

Why doesn’t the calculated risk change when I change the patient’s grade of non-proliferative diabetic retinopathy from mild to moderate or vice versa?
Risk of progression to STR greatly depends upon the presence of any DR, and the available data does not allow for accurate stratification of risk based upon mild and moderate levels of NPDR. Any patient with severe NPDR is at substantial short term risk of progression to STR, irrespective of metabolic control or changes thereof, and must be monitored closely or referred to a retinal specialist for possible treatment.

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