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Catherine Awad, Samantha Slotnick, Sanjeev Nath, Jerome Sherman; iVue® iWellnessExam™ has High Sensitivity and Specificity. Invest. Ophthalmol. Vis. Sci. 2012;53(14):826.
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The purpose of the study is to determine the ability of the iWellnessExam™ SD-OCT screening protocol (available on the iVue® SD-OCT, Optovue, Inc., Fremont, CA) to provide data sufficient for a clinician to accurately identify patients with known retinal and/or optic nerve (ON) pathology (sensitivity) and to accurately identify normal, healthy patients as normal (specificity).
Two groups of patients were examined: A "Confirmed Normal" (CN) cohort for the specificity aspect of the study, and a "Confirmed Disease" (CD) cohort for the sensitivity aspect of the study. 105 of the 111 CN and 102 of the 108 CD subjects were included for analysis. Of the CD patients, 68 had retinal pathology; 50 had ON pathology. (Sixteen (16) fell into both categories, with both retinal and ON pathology.)All subjects were screened on the iWellnessExam™ protocol. Screen shots of the OD, OS, and OU comparison data were obtained and deidentified for reviewer analysis by a well-trained eye care clinician. Based on these data alone, each subject was sorted into one of four categories: (1=Normal, 2=Retinal disease, 3=ON disease, 4=Retinal+ON disease).
Of the CNs, 104 of 105 were identified as normal (Specificity =99%). Of the CDs, 97 of 102 were properly identified with retinal and/or ON disease (sorted as category 2, 3, or 4), 63 of 68 of the retinal pathology subjects were detected (sorted as category 2 or 4), and 45 of the 50 ON pathology subjects were detected (sorted as category 3 or 4), (Sensitivity of 95%, 93%, and 90%, respectively). None of the Category 2 subjects were mis-sorted as Category 3, and none of the Category 3 subjects were mis-sorted as Category 2.
The iWellnessExam™ screening protocol provides data for the efficient, effective identification of both retinal and ON pathology, with high specificity and sensitivity when reviewed by a well-trained eye care clinician. It would be valuable to repeat the study with a novice and/or student clinician reviewing the same data set to ascertain inter-observer variability, as well as the impact of clinical experience on accurate referral, based on the screening data.
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