June 24, 2014
TAKE-HOME MESSAGE
- This prospective, sequential, masked clinical trial enrolled 237 patients to compare the InflammaDry test with clinical assessment (tear break-up time [TBUT], Schirmer tear testing, and corneal staining) for the confirmation of dry eye. InflammaDry had a total positive agreement of 81% (127/157) and negative agreement of 98% (78/80). The authors demonstrate that untrained technicians can confirm a dry eye diagnosis with a simple test to determine elevated levels of the inflammatory marker matrix metalloproteinase-9 in the tears.
- This objective test showed very good agreement with clinical assessment of TBUT, Schirmer testing, and corneal staining in the diagnosis of dry eye disease.
– Kathy F. Freeman, OD, FAAO
ABSTRACT
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.
Cornea
Prospective, Multicenter, Clinical Evaluation of Point-of-Care Matrix Metalloproteinase-9 Test for Confirming Dry Eye Disease
Cornea 2014 Jun 24;[EPub Ahead of Print], R Sambursky, W Davitt, M Friedberg, S Tauber