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Peter K. Kaiser, Andrew N. Antoszyk, Alexander M. Eaton, Yi-Zhong Wang, Dirk Sauer, Annemarie Weisberger, Andreas Weichselberger, Craig H. Smith, 2407 Study Group; A Pilot Multicenter Clinical Study to Evaluate a Mobile Computing System for Remote Monitoring of Retinal Function in Ranibizumab-Treated Neovascular Age-Related Macular Degeneration (AMD). Invest. Ophthalmol. Vis. Sci. 2012;53(14):4403.
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The Health Management Tool (HMT) is a novel computing system consisting of a mobile handheld device, the patient-facing component, and a database to collect and review data. This study evaluated the ability of the HMT to remotely monitor retinal visual function via software applications that measured shape discrimination hyperacuity (SDH) and collected safety-related patient-reported outcome (PRO) data in patients with neovascular AMD treated with ranibizumab. Usability of the HMT was also assessed.
Patients were enrolled in this single-arm, open-label, 16-wk pilot study if they met these key inclusion criteria: active choroidal neovascularization (CNV) secondary to AMD in at least 1 eye (either newly diagnosed or successfully treated <1 year), eligible for ranibizumab therapy, and best-corrected visual acuity (BCVA) letter score 24 (~20/320 Snellen) or better on an ETDRS chart at 4 m. Patients performed the handheld SDH test (myVisionTrackTM) on the HMT device (iPhone® 3GS) daily remotely and at clinic visits. Patients were evaluated in the clinic every 4 wk with ETDRS chart for BCVA, a standard dilated ophthalmic examination, and optical coherence tomography (OCT). Data entered into the HMT device were collected in the HMT database, which generated reminders to patients and alerts to clinicians. Ranibizumab injections logged into the HMT database prompted reminders for patients to complete a PRO questionnaire 3 d later. The study was designed to define threshold SDH scores for CNV at baseline and for monthly disease progression, as determined by investigators’ clinical judgment. Correlations between SDH scores and BCVA and OCT, and patient adherence with daily SDH testing and PRO questionnaires, were also assessed.
160 patients (ages 49-92) with newly or recently diagnosed neovascular AMD from 24 centers in the US were enrolled in this study. Approximately 90% of handheld SDH scores were available at abstract submission.
The HMT, a novel system for monitoring retinal function and PROs outside the clinic, has the potential to measure clinically meaningful change in neovascular AMD.
Clinical Trial: :
http://www.clinicaltrials.gov NLM has not yet issued a NCT number
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