Peripherex Home Visual Field Demonstrates High Test-Retest Reliability, Validity

Justin Schweitzer,1 Mitch Ibach,1 John Berdahl,1 Myra Daoud,2 Yahya A Daoud,2 Yitzi Kempinski,3 Jeffrey L Goldberg4 1Vance Thompson Vision, Sioux Falls, SD, USA; 2D&D Statistical Consultants, Oakland, CA, USA; 3Peripherex, Inc., and Umoove, Inc., Jerusalem, Israel; 4Byers Eye Institute, Stanford University, Palo Alto, CA, USACorrespondence: Jeffrey L Goldberg, Byers Eye Institute at Stanford University, 2452 Watson Ct, Palo Alto, CA, 94025, USA, Email [email protected]: Assessment of disease and progression is one of the greatest unmet needs in glaucoma care. Moving visual field testing into the home stands to increase access and increase testing frequency to address these unmet needs. Here, we test a novel home-based app (Peripherex Visual Field Test or PRX-VFT) that leverages eye tracking in a short, “gamified” software environment, against in-office Humphrey Field Analyzer (HFA) data.Methods: Observational, multicenter, open-label clinical trial in patients diagnosed with glaucoma, glaucoma suspect, or ocular hypertension.Results: A total of 190 PRX tests were performed with 97 on the left eye and 93 on the right eye, derived from 36 eyes of 19 patients who also had reliable, matched HFA data. Patients were 58% female with a mean (SD) age of 61.5 (11.9) years (range 26– 78). Test-retest reliability was good, with interclass correlation coefficient of 0.7596. Detection of abnormal fields was excellent, with a sensitivity of 95.7% and a negative predictive value (NPV) of 98.27%. Detection of normal fields was very good, with a specificity of 79.26% and a positive predictive value (PPV) of 66.36%. Patients reported that compared to HFA, PRX-VFT was easier and more fun to complete.Conclusion: In-home visual field testing using PRX-VFT on a patient’s personal computer met its primary clinical trial endpoints, was feasible, and showed excellent statistical correlation to in-office HFA testing. PRX-VFT represents an opportunity for enhancing patient care at minimal additional equipment cost to the patient or healthcare system.Plain Language Summary: The Peripherex Visual Field Test (PRX VFT) uses a patient’s home computer or laptop with built-in eye tracking and patented algorithms. For this study, the PRX VFT was tested in the real-world, in-home setting, compared to in-office Humphrey visual field tests. The PRX VFT used at home showed excellent statistics against in-office testing, meeting primary endpoints in an IRB-approved multicenter clinical trial for FDA registration. These data support in-home use of the PRX VFT by the eye care provider for screening and monitoring in glaucoma, and may be extended to the screening and monitoring of other retinal, optic nerve and neurological diseases.Keywords: visual field test, glaucoma, home healthcare, prospective clinical trial