The RPS InflammaDry Detector™ is intended to detect elevated MMP-9 in human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
The purpose of this clinical trial was to determine the sensitivity and specificity of InflammaDry compared with the clinical assessment of dry eyes. Patients were screened using clinical history and signs. Clinical history was performed using the Ocular Surface Disease Index (OSDI) and evaluated for clinical signs: * positive vital staining of the ocular surface, * decreased tear breakup time (TBUT), * reduced corneal sensitivity, and * decreased functional visual acuity Last, an independent health care professional masked to the clinical evaluation was asked to analyze each InflammaDry test result, independently confirming each result.
Study Type
OBSERVATIONAL
Enrollment
206
A noninvasive immunoassay for detecting MMP-9 levels in tears
Manatee Sarasota Eye Clinic
Bradenton, Florida, United States
Center for Excellence in Eye Care
Miami, Florida, United States
St. John's Clinics
Springfield, Missouri, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes.
Patients were assessed for signs and Symptoms of Dry Eye using OSDI (Ocular Surface Disease Index), TBUT (Fluorescein Tear Break-up Time), Corneal fluorescein staining and Schirmer Tear Test and compared to the results of the tested device. Sensitivity is the percentage of true positive cases correctly identified by the test, compared to clinical assessment. Specificity is the percentage of true negative cases correctly identified by the test, compared to clinical assessment.
Time frame: 15 minutes
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Physician Eyecare of NY
New York, New York, United States
Weill-Cornell Medical College
New York, New York, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
William F. Davitt, III, MD
El Paso, Texas, United States