Clinical investigation status 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: 17:00

Venue: Boulevard A

First Author: : L.Nichamin USA

Co Author(s): :                  

Abstract Details

Purpose:

The purpose is to report on the status of 2 clinical investigations of the FluidVision® AIOL (PowerVision, Inc., Belmont, CA, USA). A pilot study was performed at a single center (Optimed Eye and Laser Centre, Pretoria, South Africa) enrolling 20 patients. A multicenter investigation has been initiated to enroll a total 115 eyes between 3 sites in South Africa and 4 sites in Germany.

Setting:

Multicenter clinical investigation: Optimed Eye and Laser Centre, Pretoria, SA (Frik J. Potgieter, M.B. Ch.B., Paul Roux, M.D.), Visiomed Laser Eye Centre, Johannesburg, SA (Michael A. Muller, M.B. Ch.B), John Hill Eye Laser Centre, Cape Town, SA (John Hill, M.D.), Department of Ophthalmology, Ruprecht-Karls University of Heidelberg, Heidelberg, DE (Gerd F. Auffarth, M.D., Michael Holzer, M.D.), Augentagesklinik am Spreebogen, Berlin, DE (Manfred Tetz, M.D.), Ruhr University Eye Hospital, Bochum, DE (Burkhard Dick, M.D.), and Charlottenklinik fur Augenheilkunde, Stuttgart, DE (Gangolf Sauder, M.D.)

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 the optic thickness and optical power. During disaccommodation fluid flows back into the haptics and the power decreases. The pilot study enrolled 20 patients with follow-ups at 1 day, 1 week, 2 weeks and at 1, 3, 6, and 12 months with routine ophthalmological examinations and multiple measures of accommodation and accommodative amplitude. The multicenter trial will enroll 115 eyes with follow-ups at 1 day, 1 week, and 1, 3, 6, and 12 months. All pilot patients and at least the first 25 multicenter patients will be monocular implants. Subsequent patients may be binocular implants.

Results:

At 6 months all patients had excellent distance BCVA, average 20/19, and very good intermediate and near VA with best distance correction (BCDIVA, BCDNVA), average 20/26 and 20/33 respectively. Average accommodation by defocus testing was 4.0 D with all patients showing at least 2.5 D. Objective accommodation measured with the Grand Seiko autorefractor was 1.9 D using alternating near and far targets with dynamic data collection. Refractions were stable between 3 and 6 months and there were no clinically significant complications with the lens implant. Implantation of this injectable lens is comparable to a standard IOL implant procedure. The multicenter trial was initiated in January 2014 and 7 centers are expected to contribute. At the time of the presentation most pilot study patients will have completed 1 year and about 40 multicenter patients will be at 3 months.

Conclusions:

The FluidVision AIOL demonstrates true accommodation in the eye and is stable out to the 6-month follow-up. 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