Novel device designed for pupil enlargement, stabilization in IFIS eyes

Reviewed by Gerald P. Clarke, MD

A new horseshoe-shaped silicone device (Clarke Horseshoe, ReaLens LLC) for pupil enlargement and iris stabilization in cases of intraoperative floppy iris syndrome (IFIS) should soon be on the market.

The device, which is injected through a 2.4-mm incision, unfolds to naturally and gently enlarge the pupil and intraoperatively prevent iris prolapse, said Gerald P. Clarke, MD, Optivision Eyecare, Oshkosh, WI, who developed the product.

Courtesy of Gerald P. Clarke, MDThe dilator has a 2-mm rim that fits around the iris to hold it in the eye during surgery. It is inserted with a special injector that Dr. Clarke developed, which provides greater control during the insertion process than injecting it in a similar fashion to an IOL.

For removal, a small hook is inserted into one of the positioning eyelets in the device so that it can easily be slid out.

The horseshoe dilator may be an alternative to the Malyugin ring (MicroSurgical Technology) in some cases of IFIS, Dr. Clarke suggested. He explained that Malyugin rings and similar pupil expansion devices can cause the iris to stretch during insertion or removal, causing microtears in the sphincter and leaving the pupil slightly dilated.

Video of insertion

Dr. Clarke also observed that some rapidly expanding IOLs may become “locked into” a Malyugin ring during surgery, making it difficult for the surgeon to separate the two and correctly position the lens.

“This is a better product in the long run and it will do more for the entire problem of floppy iris,” Dr. Clarke said. “This keeps everything flat and out of the way. It gives you a nice round pupil; there are no stress points on the iris.”

As of June, the horseshoe-shaped dilator was not yet on the market pending finalization of distribution agreements; it is expected to be available later this year. An FDA 510(k) exemption has been applied for. The reusable injector will be sold separately.

Gerald P. Clarke, MD

E: gpclarke0724@yahoo.com

This article was adapted from Dr. Clarke’s presentation at the 2017 meeting of the American Society of Cataract and Refractive Surgery. Dr. Clarke owns the patent for this device and is an investor in ReaLens LLC, which distributes products.