Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Use of APX 100 Device for Expansion of Small Pupil in Cataract Surgery and Management of Intraoperative Floppy-iris Syndrome
Brief Summary:
The purpose of the study is to gather clinical data and safety information on the use of APX 100 device for small-pupil cataract surgery and the management of intraoperative floppy iris syndrome (IFIS) during cataract surgery.
The APX 100, a FDA-approved device (510K exempt), is a disposable stainless steal sterile device for mechanical expansion of pupillary diameter during intraocular surgery. The APX 100 is inserted to the anterior chamber of the eye through standard clear corneal incisions. The device is then located on the pupil's border between the iris and the anterior lens capsule and the pupil's diameter is expanded.
The APX 100 will be used in standard phacoemulsification cataract extraction surgery when small pupil diameter (<4.5 mm) is recognized preoperatively or develops intraoperatively due to IFIS.