BVI Medical announced it has concluded patient enrollment for its US-based investigational device exemption (IDE) clinical study on FINEVISION HP, the company’s newest hydrophobic trifocal intraocular lens (IOL).
Tell me about this IOL first.
FINEVISION HP is a third-generation IOL in BVI’s FINEVISION family—the first and original patent diffractive trifocal optic—made from a glistening-free (GFY) hydrophobic acrylic raw material.
The IOL features two novel patents, referred to as CoPODize, that allows for both convolution and apodization technologies to be leveraged on the whole optic surface.
How do these technologies work?
Convolution is designed to reduce and limit photopic phenomena (such as glare and halos), while apodization optimizes the energy percentage for distance vision in light of pupil management during the transition to mesopic conditions.
The target result includes achieving best visual acuities (VAs) at both near and far distances.
What other FINE IOLs are available?
BVI currently has two categories of FINEVISION IOLs: trifocal hydrophilic and trifocal hydrophobic.
The hydrophilic IOLs include the original FINEVISION available as a 25% hydrophilic acrylic IOL (MICRO F) and 26% hydrophilic acrylic IOL (POD F)
The hydrophobic IOLs include the FINEVISION TRIUMF (POD L GF), an extended depth-of-focus (EDOF) lens with an elongated DOF covered by longitudinal chromatic aberration (LCA) correction, as well as the new FINEVISION HP (POD F GF).
Now talk about this study.
The prospective, multicenter, randomized, masked, controlled IDE clinical study has enrolled 539 patients who will be followed to assess the safety and performance for the implantation of the FINEVISION HP IOL.
Results from the study will support a potential regulatory submission to the FDA for market approval in the United States.
What else to know?
According to BVI President and CEO Shervin Korangy, this particular trial is the first of a series of studies on innovative ophthalmic devices the company will be undertaking in the United States within the coming years.