Evaluation of the biocompatibility of an IOL embedded with an intraocular pressure sensor in the rabbit model

Session Details

Session Title: New IOL Optic Design

Session Date/Time: Tuesday 17/09/2019 | 16:30-18:00

Paper Time: 17:37

Venue: Free Paper Forum: Podium 1

First Author: : L.Werner USA

Co Author(s): :    V. Balendiran   C. Shumway   N. Ellis   B. Jiang   K. Kamae   N. Mamalis              

Abstract Details

Purpose:

To evaluate the first prototype of a single-piece, hydrophobic acrylic intraocular lens (IOL) with wireless implantable pressure sensor in the rabbit model. The optic houses the intraocular pressure (IOP) sensor module. A trench around the optic edge houses the antenna. A coating was applied to the IOL for biocompatibility and complete sealing. The IOL transmits IOP data automatically to an external unit.

Setting:

John A Moran Eye Center, University of Utah, Salt Lake City, Utah, USA.

Methods:

Six New Zealand rabbits had the test lens in OD, and a control lens (same biomaterial, design, dimensions) in OS. The rabbits had slit lamp examinations up to 12 weeks postoperatively. Two rabbits were sacrificed at 2, 6, and 12 weeks, and the eyes were enucleated. After evaluation from the Miyake-Apple view, all lenses were explanted, and the eyes were processed for histopathology. Wireless transmission of IOP data to the external unit was tested after surgery, on day 1 and then 3 times/week up to 12 weeks, after sacrifice and enucleation, and from a posterior view of the anterior segment.

Results:

Uveal and capsular biocompatibility were similar between test and control eyes. There were no signs of liquid infiltration within the optic of the test lens housing the IOP sensor module throughout the study. IOP data transmission from the IOL sensor to the external unit was possible at all time points, up to postmortem examination. The ideal distance between the eye and the external unit was approximately 2-3 cm. Histopathology showed no signs of untoward inflammation or toxicity in any of the eyes evaluated.

Conclusions:

In this first, preliminary study, uveal and capsular biocompatibility comparable to the control lens, as well as robustness of the hermetic seal of the sensor electronics within the IOL were demonstrated. The IOP sensor within the lenses was functional throughout this 12-week study, allowing for wireless transfer of IOP data through ocular tissues. Calibration/correction of the wireless data is currently being optimized for appropriate clinical interpretation of the IOP measurements obtained via the intraocular sensor.

Financial Disclosure:

research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented