PALM DESERT, CA (October 4, 2019) There is great news from both south and north of the border for people who suffer from Age-Related Macular Degeneration or Diabetic Retinopathy.
Mexico's State Institute of Ophthalmology has approved the protocol for a clinical patient trial to be conducted in Mexico City for the Nova Oculus II medical device. The trial will involve 60 patients treated by three ophthalmologists.
Training sessions for the ophthalmologists have already begun. Salud Elite, the Mexican rights-holder for the Nova Oculus device, has committed to investing up to $2 million US in securing the necessary government regulatory approvals to commercialize the device in Mexico.
Meanwhile, in Canada, the approved patient clinical trial for the Nova Oculus II is already underway. The protocol for the trial is the same as in Mexico, with 60 patients taking part. The trial is being conducted in Vancouver, B.C. by the Canadian rights-holder for the Nova Oculus II device, the Eye Machine Canada Inc.
Kevin Parkinson, an ophthalmologist in Coquitlam, B.C. is the primary investigator leading the trial. About 30 optometrists in the metro Vancouver area have been recruited to refer patients with Age-Related Macular Degeneration for participation. The Washington state-based Western Institutional Review Board will confirm the trial's investigators and testers have the necessary qualifications and the protocol approved by the Canadian government is being implemented correctly. If successful, the trial could lead to commercialization of the Nova Oculus II in Canada.
The Canadian government's regulator for medical devices, Health Canada, gave its consent for that clinical trial to begin back in July.