HumanOptics CUSTOMFLEX ARTIFICIALIRIS Mode D'emploi page 8

by the preoperative iris and anterior segment anatomy and pathology. The With Fiber
model is generally used when suture fixation is planned, whereas the Fiber Free model is
designed for sutureless implantation techniques. For placement in the capsular bag, only
the Fiber Free version should be used. See section "General Surgical Procedure" for further
considerations and a description of implantation techniques.
Important considerations for preparing the device:
• Capsular Bag Trephining: When implantation in the capsular bag is planned, the
CUSTOMFLEX® ARTIFICIALIRIS should be trephined to an appropriate size. For an adult
eye with an average-sized natural lens, the appropriate diameter is typically 10.0 mm,
though it can vary from patient to patient. The capsular bag diameter should be
estimated based on the size of the evacuated capsular bag once a capsular tension
ring has been placed, especially in smaller eyes, pediatric eyes, larger myopic eyes, or
megalo-ophthalmic eyes.
• Ciliary Sulcus Trephining: For passive placement into an anatomically suitable ciliary
sulcus, the iris device should be trephined to the estimated smallest diameter of the
ciliary sulcus.
• Always use sharp, sterile instruments for cutting or trephining the CUSTOMFLEX®
ARTIFICIALIRIS.
• The CUSTOMFLEX® ARTIFICIALIRIS can be delivered via forceps or Injector. Suitable
injection systems may be inquired about or purchased from the manufacturer.
• When suturing the CUSTOMFLEX® ARTIFICIALIRIS With Fiber model, the suture pass
should be at least 1 mm away from the edge in order to guarantee the stability of
the device after suturing and thereby minimizing the risk of device decentration or
dislocation.
12. General surgical procedure
12a. Anterior segment preparation
The anterior segment should be appropriately prepared by cataract removal and IOL
placement, and/or vitrectomy, as dictated by the preoperative anterior segment anatomy
and pathology, in preparation for implanting the device by one of the surgical methods
described below. The limbal-corneal wound should be of adequate size for the selected
delivery method. Typically a 2.75 mm wound is required to insert the device, and at least
a 4 mm wound is required if forceps will be used to insert the device.
12b. Capsular bag placement
The Fiber Free model should be used for placement of the iris device within the capsular
bag. The anterior segment should be appropriately prepared, as described in the "Anterior
Segment Preparation" section above. The anterior capsule should be stained with trypan
blue or indocyanine green at the beginning of the surgical procedure. A capsular tension
ring is inserted into the capsular bag to prevent post-operative retraction of the capsule
with subsequent tilt and decentration of the artificial iris device. The selected IOL is
then implanted in the capsular bag. The limbal-corneal wound should be enlarged, if
necessary, for implantation of the iris device. During the procedure, the anterior chamber
should be deepened as much as possible by a cohesive ophthalmic viscosurgical device
(OVD) to allow adequate space for the iris device to unfold, minimizing contact with other
intraocular structures. If the initial dye has faded, additional trypan blue or indocyanine
green may be applied or instilled along the anterior capsule margin just prior to iris
device implantation.
The iris device is either folded for implantation with forceps or rolled and placed in the
injection cartridge with the colored side outward. The leading edge of the folded device
should be placed under the distal capsule margin, visualized by noting the trypan blue
or indocyanine green over the iris device, before the iris device is unfolded. It should be
allowed to unfold with the edges of the implant oriented posteriorly (curled with the
colored side outward), so that contact with the corneal endothelium is minimized.
A spatula can guide the unfolding or injecting process. Once the iris device is unfolded,
the edges can be completely tucked into the capsular bag, with care being taken to avoid
undue pressure on the bag margins, especially in patients with congenital aniridia. The
iris device can be manipulated either by hooks or micrograsping forceps to facilitate
positioning. If the iris device does not go into the bag easily, grasping it with intraocular
microforceps at the pseudopupil margin and folding it can facilitate implantation. Once
the IOL and iris device are centered and stability is confirmed, the OVD can be removed.
If the chamber shallows, the iris device may escape from the capsular bag and require
repositioning. Removal of the OVD using a bimanual approach may help to maintain a
deep chamber and avoid dislocation of the artificial iris. The incision should be sealed
and secured according to surgeon's preference. Instillation of intraocular carbachol is
recommended to reduce the risk of post-operative pressure elevation.
12c. Passive sulcus placement
Either the With Fiber or Fiber Free model of the iris device can be used for implantation
in the ciliary sulcus without suture fixation. If suture fixation is necessary, the With
Fiber model should be used. The anterior segment should be appropriately prepared,
as described in the "Anterior Segment Preparation" section above. The iris device should
be trephined to the estimated sulcus size, as measured preoperatively by ultrasound or
intraoperatively by direct measurement of the pressurized globe. The limbal-corneal
incision should be of adequate size. The anterior chamber should be deepened as much
as possible with a cohesive OVD to allow adequate space for the iris device to unfold,
minimizing contact with intraocular structures.
The iris device should be folded for implantation with forceps or rolled and placed in the
injection cartridge with the colored side outward. The leading edge of the folded device
should be placed in the ciliary sulcus and allowed to unfold with the edges of the implant
oriented posteriorly, so that contact with the corneal endothelium is minimized. The iris
device can be manipulated either with hooks or with a micro-grasping small-gauge
intraocular forceps to facilitate the positioning. A snug fit should be confirmed. If the iris
device appears to buckle or fits too tightly, it should be removed, trephined to a smaller
size, and then reinserted. If the iris device is freely mobile in the sulcus due to the device
being trephined too small, it can be removed and replaced with the standby device after
it is trephined to a larger diameter. Alternatively, gently placed and carefully tightened
suspension sutures can be placed through the scleral wall at the ciliary sulcus to prevent
movement of the device. The sutures should be tied with only enough tension to prevent
movement and achieve centration. Overtightening the sutures can tear the device if a
Fiber Free device is utilized. Once acceptable centration and stability are confirmed,
the OVD can be removed. Removal of the OVD using a bimanual approach may help to
maintain a deep chamber and avoid dislocation of the artificial iris. The incision should be
sealed and secured according to surgeon preference. Instillation of intraocular carbachol
is advised to reduce the risk of postoperative pressure elevation. Patch graft material can
be placed over fixation sutures, as deemed necessary by the operating surgeon.
12d. Sulcus placement with suture fixation to the scleral wall
The With Fiber model should be used for fixation in the ciliary sulcus with sutures.
The anterior segment should be appropriately prepared, as described in the "Anterior
Segment Preparation" section above. The iris device should be trephined to at least
1 mm less than the estimated sulcus size, as measured preoperatively by ultrasound or
intraoperatively by direct measurement of the pressurized globe.
The limbal-corneal incision should be of adequate size. The anterior chamber should be
deepened as much as possible by a cohesive OVD to allow adequate space for the iris
device to unfold, minimizing contact with intraocular structures.
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