OCT 07, 2020
This prospective, first-in-human clinical trial assessed the safety and efficacy of a wireless photovoltaic retinal implant (PRIMA; Pixum Vision) in patients with geographic atrophy.
The implant was tested 5 patients with geographic atrophy zone of 3 optic disc diameters or more and BCVA of 20/400 to 20/1,000 in the worse-seeing study eye. Fundus photography and OCT were used to assess anatomic outcomes during the 12-month follow-up. Prosthetic vision was evaluated by mapping light perception, bar orientation, letter recognition and Landolt C acuity testing.
The prosthesis was implanted successfully under the macula in all 5 patients, however it was implanted within the choroid of 1 patient and was off center by 2 mm in another patient. None of the patients’ vision declined after placement. All participants could perceive white-yellow prosthetic visual patterns with adjustable brightness in the previous scotomata, which did not perceive light prior to the surgery. The 3 patients with optimal placement of the implant achieved visual acuity of 20/460 to 20/550.
This was a small, initial, open-label study with only 5 patients.
This is an exciting new technology that provides vision restoration potential to patients with end stage geographic atrophy. This study demonstrated that the use of photovoltaic cells in the subretinal space is safe, feasible and can lead to improved visual acuity.