PM1 - Clinical, Technical and Regulatory Update
On Monday 19th December, we were joined by a team of Senior Clinicians from Moorfields Eye Hospital NHS Foundation Trust and John Lawrenson Professor of Clinical Visual Science from City University, London, who will be conducting our clinical trials. This orientation day represents the first step to fulfilling the planning requirements in preparation to start the clinical study in January.
The study will assess how closely the eye measurements taken from the PM1 match eye measurements taken from other devices that are currently on the market. The goal is to validate a compact handheld meter that is fast and easy to use without the need to contact the eye. Over the course of a few days during the trial, we will invite between 82 and 100 volunteers to the study, and each will be tested by a clinician using a PM1 and other devices.
The research data will be submitted along with the rest of the technical file for PM1 to DARE, our Notified Body for CE marking and we anticipate also submitting for UK CA marking at the same time.
Occuity CEO Dan Daly Commented:
“It was great to host the clinical trials orientation day and see the team of senior clinicians from City University, London, get hands-on with the PM1 for the first time. Within minutes they were taking eye measurements from one another and members of the Occuity team.”
The PM1 is scheduled for launch in 2023. Find out more here.