Fluid-based accommodating IOL yields strong visual acuity in sighted eyes
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Louis D. "Skip" Nichamin |
BOSTON — A fluid-driven accommodating IOL yielded promising results in early clinical trials, a speaker said here.
Louis D. "Skip" Nichamin, MD, presented results of a phase 2 clinical trial for the FluidVision accommodating IOL (PowerVision) at the American Society of Cataract and Refractive Surgery meeting.
The study was the first involving the lens implanted in sighted eyes. A phase 1 trial tested accommodative motion in severely glaucomatous eyes, Dr. Nichamin said.
"Our early results in the very first sighted eyes to be implanted with the FluidVision lens are showing excellent visual acuity in general and offer an average greater than 5 D of accommodative power by the way of internal movement," Dr. Nichamin said. "The FluidVision lens mimics the natural accommodative process of our crystalline lens with a shape change and forward movement. This is all achieved through a standard technique."
The trial included six patients who underwent lens implantation. Primary outcome measures were visual acuity testing and accommodative response. Optical coherence tomography was used to measure the range of accommodative movement.
Results showed that all patients had postoperative visual acuity of 20/20 or better, and all were within 1 D of emmetropia. The lens provided an average of 5.6 D of accommodative power. Three patients had 6.5 D of accommodation, Dr. Nichamin said.
OCT imaging showed that average internal lens movement was 100 µm at 3 months postoperatively. That movement correlated with 5 D to 6 D of accommodation.
Investigators plan to implant the lens in a total of 20 eyes and hope to have an injectable delivery system later this year. The next generation FluidVision lens may have the potential to improve accommodative power by 50%, Dr. Nichamin said.
Accommodation is associated with a change in the shape of the crystalline lens when the elastic forces of the lens capsule are released during contraction of the ciliary body, thereby increasing both its dioptric power and negative spherical aberration. A 5 D accommodative effort results in a change in lens shape and curvature and around 300 µm of thickening, but only 100 µm of anterior axial movement. This demonstrates that the majority of the increase in dioptric power during accommodation is produced by changes in lens shape, rather than displacement along the z-axis. The FluidVision Lens (PowerVision Inc.) drives fluid of a polymer-matched refractive index from the soft haptics through channels to a fluid-driven internal activator. This action produces an accommodation-driven increase in the anterior curvature of the deformable optic’s anterior surface. In parallel to natural accommodation, changes in the shape of the FluidVision Lens are able to generate far greater changes in the power of the eye compared to that produced by axial lens movement alone.
– Jay S. Pepose, MD, PhD
Pepose Vision
Institute, St. Louis