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BACKGROUND/RATIONALE:
The benefits and economic impact of screening for diabetic retinopathy have been clearly demonstrated. However, adherence with regular eye care is less than optimal. New strategies have been developed to enhance screening rates, such as digital retinal imaging using store-and-forward technology (tele-retinal imaging). While tele-retinal imaging may be sufficient to identify diabetic retinopathy, we do not know its ability to diagnose concomitant non-diabetic eye diseases, such as glaucoma and cataracts. These other diagnoses might be missed among individuals enrolled solely in a tele-retinal imaging screening program. Other non-invasive testing that match components of the complete eye exam (e.g. visual acuity, intra-ocular pressure) may supplement results of retinal imaging, increasing its diagnostic agreement to the level of a complete eye exam.
We hypothesize that tele-retinal imaging supplemented with a non-invasive eye care assessment (hereafter referred to as a Technology Assisted Ophthalmic [TAO] exam) can serve as an alternative to a complete eye exam in screening patients with diabetes.
OBJECTIVE(S):
The study employs a prospective, observational design in which participants will have both a TAO exam and a complete eye exam performed by independent examiners. The two exam modalities will be compared for level of agreement, sensitivity, specificity and predictive value for the following outcome measures: eye care referrals, level of diabetic retinopathy, and the presence of other referable non-diabetic ocular disease. We will also complete a cost effectiveness analysis.
METHODS:
The study will enroll 500 participants with diabetes. We will evaluate the baseline level of agreement of the TAO exam and the complete eye exam. This provides the best opportunity for assessing agreement in diagnosing all levels of prevalent diabetic retinopathy, non-diabetic ocular pathologies, and referral for further eye care. We will then prospectively follow a subset of individuals with no retinopathy or mild retinopathy over a 2 year period, examining them every 12 months with both TAO and complete eye exams, to determine the level of agreement for incident retinopathy and/or non-diabetic eye diseases. We will then assess the economic impact of tele-retinal imaging in comparison to a complete eye exam, using a cost-minimization approach.
FINDINGS/RESULTS:
There are no findings to date.
IMPACT:
Tele-retinal imaging is assuming a role in the care of patients with diabetes, largely based on empirical data. This trial will prospectively evaluate the clinical benefit and economic impact of an enhanced tele-retinal imaging exam in screening patients with diabetes for eye diseases.
PUBLICATIONS:
None at this time.
DRA:
Chronic Diseases, Health Services and Systems
DRE:
Diagnosis and Prognosis
Keywords:
Cost effectiveness, Screening, Telemedicine
MeSH Terms:
none
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