A Novel Mobile e-health Self-monitoring Test for Macular Diseases


ABSTRACT

Objective:

To present a novel mobile e-health self-monitoring test for macular diseases and its ability to identify the worsening of wet AMD early within a pro re nata (PRN) antiVEGF treatment scheme.

Methods:

We developed a novel so called dot alignment test Alleye ® to measure hyper acuity. Patients can perform this test at home on portable devices. Results can be transferred online to the treating physician. In a prospective, cohort study we assessed the ability of the dot alignment test to detect worsening of the disease within visits in a PRN treatment scheme. Patients were advised to perform the test approximately all 2 to 3 days. Treating physicians were blinded to the results of the alignment test. Performance in the alignment task was quantified in a score ranging from a minimum of 0 to a maximum of 12. A change of more than -1 from baseline score was rated as worsening. Sensitivity, defined as the percentage of eyes with a positive result between two visits and needing IVI treatment at the end of the period, was calculated. Decision for injection was based on clinical and OCT results according to international guidelines.

Results:

Eighty-eight eyes with wet AMD provided 1843 dot alignment measurements in 237 one month follow-up periods. Mean age was 73.9 years (SD 10.3) and the mean BCVA at study entry was 71.9 letters (SD 13.8). The sensitivity of the test to detect worsening in-between clinical visits was 90.8 % (95% CI: 81.9% to 96.2%). The positive predictive value, i.e. the probability, that a patient with a positive Alleye® result received an anti-VEGF injection at the next clinical follow-up visit was 53.9 % (95%CI: 44.9% to 62.8%). In a subgroup of patients, with a history of at least 10 IVI prior to study entry, the predicted probability was 65.5% (95% CI: 54.6% to 75.4%).

Conclusion:

The findings show that patient self-measurement with the dot alignment test can detect worsening of the wet AMD under antiVEGF treatment prior to clinical visits and can be therefore used to individualize management.

Disclosure:

SMK, TMA, LK and LMB are founders and shareholders of Oculocare medical inc. Oculocare medical inc. is owner of the intellectual property of Alleye®


CONTACT DETAILS

Martin K Schmid
Lucerne, Switzerland
Email : martin.schmid@luks.ch
Work Phone: +41412053360