Intraoperative Floppy Iris Syndrome Clinical Trial
Official title:
Use of APX 100 Device for Expansion of Small Pupil in Cataract Surgery and Management of Intraoperative Floppy-iris Syndrome
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.
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 regarding
the intraoperative use of the device and its effect on ocular tissues and final visual
acuity will be documented in the patients' files.
The preoperative visit will include a thorough eye examination, visual acuity test,
intraocular pressure measurement, subjective refraction, measurements to decide the
intraocular lens power, endothelial cell counts, corneal topography and anterior segment
photography. The second visit will be the cataract extraction surgery itself during which
the APX 100 device will be used. On the first postoperative day visual acuity will be
tested, intraocular pressure will be measured, a thorough eye examination will be performed
and treatment with topical third-generation fluoroquinolone antibiotics and corticosteroids
drops will be initiated. Examination one week postoperatively will be the same as in the
previous visit, only the topical treatment regimen will be changed - topical antibiotics
will be stopped and the dosage of the corticosteroids drops will be lowered and maintained
for additional three weeks. The last study visit, 1 month postoperatively, will include
subjective refraction, best corrected visual acuity, a thorough eye examination, intraocular
pressure measurement, endothelial cell counts, corneal topography and anterior segment
photography.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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