6 month pilot study with the next generation fluid-filled accommodating intraocular lens

Session Details

Session Title: New IOLs: Material & Preload IOL

Session Date/Time: Monday 24/09/2018 | 08:00-10:30

Paper Time: 08:27

Venue: Room A3, Podium 2

First Author: : L.Nichamin USA

Co Author(s): :                        

Abstract Details

Purpose:

The purpose is to summarize visual outcomes with the next generation fluid filled accommodating intraocular lens, the FluidVision™ MX AIOL (PowerVision, Inc., Belmont, CA, USA), in a pilot clinical study. This trial with 6-month follow-up was performed at 6 sites in South Africa. The FluidVision MX 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.

Setting:

Dr. Potgieter (Optimed Eye and Laser Centre, Pretoria), Dr. van Helsdingen (Somerset Eye Clinic, Cape Town), Drs. Cook and Boliter (The Eye Centre, East London), Dr. Wassermann (Umhlanga Medical Centre, Durban), Dr. Venter (Pasteur Medical Centre, Bloemfontein) and Drs. van Velden and Albrecht (1 Military Hospital, Cape Town).

Methods:

This monocular implant pilot study enrolled 28 subjects with 14 females and 14 males. The average age was 66 and the range was from 51 to 82 years old. One subject exited early. The lens was implanted through a 3.5 mm incision using the PowerJect™ Inserter. Subjects were followed-up at 1 day, 1 week and 1, 3 and 6 months measuring visual acuities at 4 meters, 66 cm and 40 cm and contrast sensitivity using a semi-automated computer driven system.

Results:

Follow-up data on 27 subjects at the 6-month termination was obtained. Best monocular corrected distance VA was stable averaged logMAR -0.05 at 6 months. Distance corrected intermediate and near VAs averaged logMAR 0.05 for intermediate and logMAR 0.14 for near for the same period. Objective accommodation up to 4.1 D was measured by autorefractor. Average mesopic contrast sensitivity was equivalent to an age adjusted reference population. The FluidVision MX AIOL was easily injected into the capsule through a 3.5 mm incision.

Conclusions:

The FluidVision MX AIOL demonstrates excellent and stable monocular visual acuity at distance, intermediate and near. Visual acuity, objective accommodation and contrast sensitivity demonstrated vision quality equivalent to a monofocal all distances. The lens is easily injected into the capsule.

Financial Disclosure:

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