Clinical Trial: Use of APX 100 Device for Small-pupil Cataract Surgery and Intraoperative Floppy-iris Syndrome

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.


Detailed Summary:

In cases of small-pupil cataract surgery and intraoperative floppy iris syndrome (IFIS) the potential of intraoperative complications is substantial. The risk of posterior lens capsule tear, dropped nucleus fragments and vitreous loss increases.

There are several surgical methods and commercial products designed to deal with small pupil diameter in ocular surgery. Among these, pupil viscodilation with ophthalmic viscosurgical devices, mechanical dilation of pupil with ocular spatula, radial incisions in pupil's sphincter and iris retractors (iris hooks, Malyugin ring, Perfect Pupil ring), are the most popular. Each method has its advantages and disadvantages.

Our group developed an innovative iris retractor device named APX 100. It is a disposable stainless steal sterile device designed for mechanical expansion of pupillary diameter during intraocular surgery. The device was approved by the FDA (510K exempt) for iris retraction in small pupil diameters and in IFIS. It comes in a disposable kit with 2 iris retractors and 2 forceps.

The study was designed to help us gain more clinical knowledge about the surgical advantages and safety of APX 100 beyond registration data.

Patients designated for standard phacoemulsification cataract extraction with small pupil diameter or with documented IFIS in previous eye will be enrolled to the study. The APX 100 will be used intraoperatively in order to retract the iris and expand the pupil. All other cataract extraction surgical stages will remain unchanged.

The study includes five study visits: preoperative examination, cataract extraction surgery, first postoperative day, 1 week postoperatively, 1 month postoperatively. All data regardin
Sponsor: Meir Medical Center

Current Primary Outcome: Efficacy of APX 100 device [ Time Frame: 6 months ]

To assess the degree of pupil expansion by measuring the pupil diameter in millimeters after positioning the APX 100 device appropriately in small-pupil cataract surgery and in the management of intraoperative floppy iris syndrome (IFIS).


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety of APX 100 device [ Time Frame: 6 months ]

To assess the rate of the possible adverse effects on ocular tissues (cornea, iris, lens and ciliary body) by the use of APX 100 device.


Original Secondary Outcome: Same as current

Information By: Meir Medical Center

Dates:
Date Received: September 19, 2012
Date Started: September 2012
Date Completion:
Last Updated: April 15, 2015
Last Verified: September 2012