title: Validation and verification of the OPI 2.0 System.
abstract: OBJECTIVE
  The Ocular Protection Index (OPI) 2.0 System was developed to evaluate ocular surface protection under a natural blink pattern and normal visual conditions. The OPI 2.0 System implements fully automated software algorithms which provide a real-time measurement of corneal exposure (breakup area) for each interblink interval during a 1-minute video. Utilizing this method, the mean breakup area (MBA) and OPI 2.0 (MBA/interblink interval) were calculated and analyzed. The purpose of this study was to verify and validate the OPI 2.0 System for its ability to distinguish between dry eye and normal subjects, and to accurately identify breakup area.
  
  
  METHODS
  In order to verify and validate the OPI 2.0 System, a series of artificial images and a series of still image frames captured during an actual clinical session using fluorescein staining videography were analyzed. Finally, a clinical validation process was completed to determine the effectiveness and clinical relevance of the OPI 2.0 System to differentiate between dry eye and normal subjects.
  
  
  RESULTS
  Software analysis verification conducted in a set of artificially constructed images and in actual videos both saw minimal error rates. MBA and OPI 2.0 calculations were able to distinguish between the qualifying eyes of dry eye and normal subjects in a statistically significant fashion (P < 0.001 for both outcomes). As expected, dry eye subjects had a higher MBA and OPI 2.0 than normal subjects (0.232, dry eye; 0.040, normal and 0.039, dry eye; 0.006, normal, respectively). Results for the worst eyes and all qualifying analyses based on staining, forced-stare tear film breakup time, and MBA were numerically similar.
  
  
  CONCLUSIONS
  The OPI 2.0 System accurately identifies the degree of breakup area on the cornea and represents an efficient, clinically relevant measurement of the pathophysiology of the ocular surface.
authors.affiliation: School of Computing, Informatics, and Decision Systems Engineering, Arizona State University, Tempe, AZ.
authors.forename: Richard
authors.initials: R
authors.lastname: Abelson
authors.forename: Keith J
authors.initials: KJ
authors.lastname: Lane
authors.forename: John
authors.initials: J
authors.lastname: Rodriguez
authors.forename: Patrick
authors.initials: P
authors.lastname: Johnston
authors.forename: Endri
authors.initials: E
authors.lastname: Angjeli
authors.forename: George
authors.initials: G
authors.lastname: Ousler
authors.forename: Douglas
authors.initials: D
authors.lastname: Montgomery