Accommodative capacity of a novel fluid filled hydrophobic acrylic accommodative intraocular lens

Session Details

Session Title: IOL Technology / Accommodative IOLs etc.

Session Date/Time: Saturday 13/09/2014 | 16:00-18:00

Paper Time: 16:16

Venue: Boulevard A

First Author: : P.Roux SOUTH AFRICA

Co Author(s): :    F. Potgieter   L. Nichamin           

Abstract Details

Purpose:

The purpose is to demonstrate the clinical accommodative capacity of the FluidVision® AIOL (PowerVision, Inc., Belmont, CA, USA).

Setting:

Optimed Eye and Laser Centre, Pretoria, South Africa

Methods:

The FluidVision AIOL consists of a refractive index matched silicone fluid filled optic connected by channels to two fluid filled haptics. The act of accommodation forces fluid from the haptics into the optic thereby increasing thickness and optical power. During disaccommodation fluid flows back into the haptics. A 20 patient pilot clinical investigation was performed at a single center with two surgeons (PR, FP). Patients were followed-up at 1day, 1 week, 2 weeks and at 1, 3, 6, and 12 months with routine ophthalmological examinations and multiple measures of accommodation and accommodative amplitude. At the 1, 3, 6, and 12 month follow-up periods the center-to-center thickness of the FluidVision AIOL was measured by Optical Coherence Tomography (OCT) first after administration of cyclopentolate and then 3 days later after administration of pilocarpine. In vitro measurements demonstrated an excellent correlation of change in lens thickness with change in lens power.

Results:

In vitro testing of the FluidVision AIOL demonstrated a change in power of 1.0 D with change in thickness of 0.019 mm. At 1 month the average accommodative capacity as measured by the difference in lens thickness between cycloplegia and pilocarpine induced cholinergic stimulation was 2.6 D. The average accommodative capacity was 2.8 D at 3 months and to 3.1 D at 6 months demonstrating a stable response of the FluidVision AIOL. The average best corrected distance VA was 20/19 (LogMAR -0.02) at 6 months. Average intermediate and near visual acuities, with distance correction in place, were 20/26 and 20/33 respectively. Accommodation was stable between 1 and 6 months. There were no clinically significant complications to the lens implant in the pilot clinical study.

Conclusions:

The FluidVision AIOL demonstrated true accommodative capacity in all 20 pilot clinical study patients. The accommodative capacity was stable at 6 months and best corrected distance visual acuity was excellent in all patients. Near and intermediate visual acuities were very good with all patients achieving spectacle free reading capability. This pilot study demonstrated that the FluidVision AIOL is capable and ready to enter a multi-center clinical trial. Excellent distance refraction shows the high optical quality of the lens. Objective accommodation meets the ISO guidelines to be labeled an accommodative IOL and subjectively the patients, best corrected for distance, see far, intermediate and near and can read without the assistance of supplemental correction.

Financial Interest:

One or more of the authors... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, One or more of the authors... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One or more of the authors... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented