Results of Pilot Study Evaluating Performance of New Fluid-Filled Injectable Accommodating IOL

Roux, Paul

Results of Pilot Study Evaluating Performance of New Fluid-Filled Injectable Accommodating IOL

Monday, April 28, 2014: 1:47 PM

Room 151A (Boston Convention and Exhibition Center)

Paul Roux, MBBS, FRCOphth, Brooklyn Ophthalmology Practice, Pretoria, South Africa

Gerd U. Auffarth, MD, David J Apple International Laboratory for Ocular Pathology and International Vision Correction Research Centre, University of Heidelberg, Heidelberg, Germany

Frik J. Potgieter, MD, FRCS, Optimed Eye and Laser Clinic, Pretoria, South Africa

Narrative Responses:

Purpose
To evaluate the safety and effectiveness of a new accommodating intraocular lens (AIOL), consisting of a hollow, fluid-filled hydrophobic acrylic optic and oversized, hollow, fluid-filled haptics. The fluid flows through channels between the haptics and optic allowing for a change in lens power.

Methods
Thirty patients were enrolled in this prospective, single-arm study of the FluidVision AIOL (PowerVision, Inc., Belmont, CA). Typical IOL study inclusion and exclusion criteria were employed, and standard safety and effectiveness endpoints were assessed. In addition, patients were assessed for intermediate (66cm) and near (40cm) visual acuity, subjective accommodation (using defocus and push-down methodologies) and objective accommodation (by auto-refractor, wavefront aberrometer and OCT). Follow-up visits occurred at weeks 1 and 2, and months 1, 3, 6 and 12.

Results
At the six-month clinical follow up, mean CDVA was 20/20, mean DCIVA was between 20/20 and 20/25, and mean DCNVA was 20/25. DCNVA improved consistently between the 1-week and 3-month follow-up visits. Depending on the method used, mean subjective accommodation measured 4D and mean objective accommodation measured 2D. No clinical complications were noted in this patient cohort.

Conclusion
Visual acuity results were very good at all distances tested, a result that was consistent with the amount of objective accommodation that was measured. In addition, the study did not identify any new safety risks associated with use of the device.