Purpose: The aim of this study was to determine the negative and positive agreement of a point-of-care matrix metalloproteinase-9 test in confirming the diagnosis of dry eye and to evaluate the ease of use by untrained ophthalmic technicians.
Methods: The study was a prospective, sequential, masked, clinical trial with 4 clinical trial sites. The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.
Results: The study enrolled 237 patients. If the OSDI is included in the definition for mild dry eye, the InflammaDry test was shown to have a total positive agreement of 81% (127/157) and a negative agreement of 98% (78/80). The removal of the OSDI shifted the categorization of 11 patients previously considered positive for dry eye to become categorized as negative for dry eye. If the OSDI is excluded from the definition of dry eye, the InflammaDry test demonstrates a positive agreement of 86% (126/146) and a negative agreement of 97% (88/91) against the clinical assessment.
Conclusions: The InflammaDry test demonstrates a high positive and negative agreement for confirming suspected dry eye disease. In addition, the test was safely and effectively performed by untrained operators. These findings support the intended use of the InflammaDry test as an aid in the diagnosis of dry eye.
*Manatee Sarasota Eye Clinic and Laser Center, Bradenton, FL;
†El Paso, TX; and
‡Ophthalmology Department, Mercy Eye Specialists, Springfield, MO.
Reprints: Robert Sambursky, MD, Manatee Sarasota Eye Clinic and Laser Center, 13946 Wood Duck Circle, Bradenton, FL 34202 (e-mail: email@example.com).
The design of the study and collection of data were sponsored by Rapid Pathogen Screening Inc (RPS). No sponsorship was received for the analysis and interpretation of study data. R. Sambursky has an affiliation with RPS but was not an investigator. The remaining authors have no funding or conflicts of interest to disclose.
Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01692964.
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Received January 08, 2014
Accepted May 03, 2014