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To report on the first results of a multi-center, prospective randomized clinical study comparing outcomes following the pre-operative use of the Vivior Visual Behavior Monitor (VBM, Vivior AG, Zurich) to assess patients’ visual needs.
This European study is a 7-site, prospective, randomized study that is enrolling presbyopia-age and cataract patients who present for treatment. Following informed consent, patients are randomized into one of two arms: 1) Wearing the VBM or, 2) each study site’s standard patient education regarding presbyopic treatment options. The VBM consists of sensors measuring key parameters including distance, ambient light, orientation and motion. The device is attached to the frames of the wearer’s glasses using a magnetic clip. Pre and post-operatively, patients were asked to complete the CatQuest 9 tool, as well as completing an exit interview at the end of the study.
The study will enroll up to 322 patients (644 eyes) at the participating sites in Germany, France, Switzerland and the Czech Republic. As of this submission, patient enrollment has already started. The primary endpoint will be the number of patients choosing an advanced technology intraocular lens (IOL) based on the use of Vivior, as well as the Cat-Q9 score and assessment if the visual outcome matched the patients’ pre-operative expectations.
The VBM is a unique wearable that can objectively track a patient’s lifestyle. This level of data is beneficial to both patient and surgeon, resulting in an individualized treatment solution, which should reduce the likelihood of patient dissatisfaction following cataract surgery and presbyopic treatments.