OnPoint Vision Initiates Phase 1 Trial of AccuraSee Intraocular Pseudophakic Capsular Lens Magnifier

OnPoint Vision announced open enrollment of the phase 1 IDE clinical trial of the AccuraSee Intraocular Pseudophakic Capsular Lens (IOPCL) Magnifier (MAG) for secondary implantation in the capsular bag with a pre-existing 6mm acrylic posterior chamber IOL.

The IOPCL MAG is neutral optic (plano power) with a central +10.0D 1.8 mm zone designed to magnify near images when unilaterally implanted in low vision pseudophakic subjects with inactive age-related macular degeneration (AMD) at least 6 months after cataract surgery, according to OnPoint. 

The IOPCL MAG was originally implanted in a first-in-human study in the US under a separate early feasibility study (EFS) IDE where enrollment is complete and patient follow-up is complete.

OnPoint Vision also announced completion of site selection for the FDA approved refractive EFS IDE to evaluate the initial safety and effectiveness of the AccuraSee IOPCL (monofocal) for secondary implantation in the capsular bag to improve near and/or intermediate vision by inducing myopia (monovision) when implanted in the non-dominant eye in up to 10 pseudophakic subjects at least 6 months after cataract surgery. This will be the second EFS of the monofocal IOPCL, whereas the FIH study of the monofocal IOPCL was conducted in low vision subjects. This first EFS was completed and closed under a separate IDE.