Sambursky Robert, Davitt William F, Friedberg Murray, Tauber Shachar
*Manatee Sarasota Eye Clinic and Laser Center, Bradenton, FL; †El Paso, TX; and ‡Ophthalmology Department, Mercy Eye Specialists, Springfield, MO.
Cornea. 2014 Aug;33(8):812-8. doi: 10.1097/ICO.0000000000000175.
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.
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.
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.
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.
本研究旨在确定即时检测基质金属蛋白酶-9在确诊干眼症方面的阴性和阳性一致性，并评估未经培训的眼科技术人员使用该检测的便捷性。
本研究是一项在4个临床试验地点进行的前瞻性、序贯性、盲法临床试验。将InflammaDry检测与泪膜破裂时间、泪液分泌试验及角膜染色的临床评估进行比较，以确诊干眼症，同时纳入眼表疾病指数（OSDI）作为确诊试验。
该研究共纳入237例患者。如果将OSDI纳入轻度干眼症的定义，InflammaDry检测显示总阳性一致性为81%（127/157），阴性一致性为98%（78/80）。去除OSDI后，11例先前被认为干眼症阳性的患者分类变为干眼症阴性。如果将OSDI排除在干眼症定义之外，InflammaDry检测与临床评估相比，阳性一致性为86%（126/146），阴性一致性为97%（88/91）。
InflammaDry检测在确诊疑似干眼症方面显示出较高的阳性和阴性一致性。此外，未经培训的操作人员能安全有效地进行该检测。这些发现支持将InflammaDry检测用于辅助诊断干眼症的预期用途。
