PowerVision Updates on OUS Trials
The FluidVision AIOL is the first “true shape-changing, fluid-driven intraocular lens (IOL),” according to PowerVision, which means it creates a continuously variable monofocal lens and mimics the eye’s natural accommodative mechanism. Implantation is virtually identical to traditional IOL surgery. The mechanism of action of the lens involves changing the radius of curvature of the natural lens by exerting pressure on the capsule and having the fluid move from the periphery of the lens to the center. Trials outside the US proved “conclusively” that the lens could produce objective accommodation, with stability tracked out to three years. The company’s FluidVision 20/20 next-generation lens has now been launched in the clinic; the pilot study in South Africa shows a defocus curve of >5 D in the preliminary six-month results (n=20), said Barry Cheskin, President, CEO, and Co-founder. Additional preliminary results are showing between 3 D and 4 D of accommodation. PowerVision is currently enrolling patients in a large, multicenter, OUS study comparing the FluidVision 20/20 with other commercially available IOLs. The company is conducting a formal validation review of its new injector (allowing the lens to be implanted through a 3.2-mm incision), is building a prototype toric accommodating IOL, and has begun exploratory work on post-implant adjustment of the lens, and allowing the lens to be implanted through a 2.8-mm incision.