Stability and safety of a fluid-filled accommodative intraocular lens implanted in the capsular bag at eighteen months follow-up

Session Details

Session Title: Pseudophakic IOLs: Multifocal & Accommodative

Session Date/Time: Monday 07/09/2015 | 08:00-10:30

Paper Time: 09:42

Venue: Room 1

First Author: : L.Nichamin USA

Co Author(s): :    F. Potgieter   P. Roux                 

Abstract Details

Purpose:

The purpose is to demonstrate stability of refraction and accommodative amplitude of a new fluid filled accommodative (AIOL) placed within the capsular bag. The FluidVision® AIOL (PowerVision, Inc., Belmont, CA, USA) consists of a refractive index matched silicone fluid filled optic connected by channels to two fluid filled haptics. The lens is implanted into the capsular bag where the act of accommodation forces fluid from the haptics into the optic, thereby increasing thickness and optical power, and upon dis-accommodation allows fluid to flow back into the haptics thereby decreasing optical power.

Setting:

A private clinic, Optimed Eye and Laser Centre, Pretoria, South Africa

Methods:

The pilot clinical investigation enrolled 26 eyes from 26 patients and was performed at a single center with two surgeons (PR, FP). All lenses were implanted into the capsular bag per protocol. Patients were followed-up at 1 day, 1 week, 2 weeks and at 1, 3, 6, 12 and 18 months with routine ophthalmological examinations and multiple measures of accommodation and accommodative amplitude. At the time of this abstract 13 patients had completed some or all of the 18 month follow-up examinations.

Results:

Average monocular best distance corrected visual acuities at 12 and 18 months were: distance logMAR 0.00 vs. 0.02, intermediate at 66 cm logMAR 0.09 vs. 0.08, and near at 40 cm logMAR 0.25 vs. 0.24. The change in manifest spherical refraction from 12 to 18 months was -0.01 D (n=11) and in cycloplegic refraction was +0.05 (n=7) in a consistent cohort. Average accommodation measured by defocus went from 3.125 to 3.25 (consistent cohort n=12) and maintained 4.1 D by pushdown (n=11). No adverse events were reported and slit-lamp examinations of the implants revealed no abnormal findings.

Conclusions:

The FluidVision lens was shown to be safe, effective and stable when implanted into the capsular bag in this pilot clinical investigation. Visual acuities at all distance, intermediate and near were stable as was manifest and cycloplegic refractions from 12 to 18 months. Accommodative amplitude was unchanged.

Financial Interest:

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