Glaucoma Eye Clinical Trial
Official title:
XEN45 Gel Stent Implantation in Glaucoma Surgery
Purpose: To report the follow-up data for patients who had XEN45 gel stent implantation, a
new method of minimally invasive glaucoma surgery (MIGS).
Material and Methods: Fifteen eyes of fifteen patients who had XEN45 gel stent implantation
surgery were investigated in the study. All the patients were examined preoperatively and at
the following postoperative time points: 1 day; 1 and 2 weeks; and 1, 2, 3, 6, and 12
months. Intraocular pressure (IOP) was measured by Goldmann applanation tonometry. Combined
surgical procedures (XEN 45 + phacoemulsification + intraocular lens) were performed in the
cases that had cataracts in addition to glaucoma.
Introduction
Glaucoma is a group of eye diseases that results in damage to the optic nerve and permanent
visual loss; more than 60 million people around the world are affected by glaucoma.
Increased intraocular pressure (IOP) is the most important risk factor for the development
of optic nerve damage and changes in the visual field. Therefore, the most effective
treatment modality is the reduction of IOP, in order to prevent glaucoma progression and
optic nerve atrophy. Trabeculectomy and episcleral aqueous drainage implants are currently
the most widely used surgical methods for reducing IOP and treating glaucoma. Unfortunately,
these procedures have potentially destructive intraoperative and postoperative
complications, such as hypotony, choroidal effusion, blebitis, and endophthalmitis.
Therefore, there is a trend of developing new surgical procedures to avoid the complications
arising from conventional surgical procedures. These new surgical methods, called "minimally
invasive glaucoma surgery" (MIGS), have some advantages over the conventional glaucoma
surgical procedures, such as ab interno applicability, the elimination of external
intervention requirements, and the ease of performance alongside cataract surgery. These
advantages allow MIGS methods to be safer and less invasive than other surgical methods.
The XEN gel stent (Allergan, Dublin, Ireland) is a recently developed, permanent, ab interno
collagen implant that reduces IOP by draining aqueous fluid from the anterior chamber into
the subconjunctival space. The stent is a hydrophilic tube that is 6 mm long and composed of
porcine gelatin crosslinked with glutaraldehyde. There are three sizes of this stent: 45 μm,
63 μm, and 140 μm, all with different inner diameters. The XEN45 gel stent is CE-marked in
the European Union, and it is indicated for the treatment of refractory glaucoma that has
proven resistant to previous surgical treatment and for patients with primary open angle
glaucoma (POAG), pseudoexfoliative glaucoma, or pigmentary glaucoma that cannot be
controlled with the maximum tolerated medical therapy. It is also licensed for use in
Canada, Switzerland, and Turkey. The XEN45 gel stent was recently approved by the U.S. Food
and Drug Administration (FDA). Because it is a new device, there are still unknown aspects
of its efficacy and safety and of the proper surgical technique for its use. This study
aimed to report the follow-up data after XEN45 gel stent implantation surgery in patients
with different types of glaucoma.
Methods
This was a retrospective, consecutive case series study. Patients who had an XEN45 gel stent
implantation surgery between January 2015 and March 2016 were enrolled in the study.
Patients were included whose refractory glaucoma was resistant to previous surgical
treatment. Patients were also included who had POAG, pseudoexfoliative glaucoma, or
pigmentary glaucoma, with uncontrolled IOP and progressive visual field damage despite using
the maximum tolerated dose of topical antiglaucomatous medications. Patients who had
previous glaucoma surgery were included as well. The exclusion criteria included primary
closed-angle glaucoma, a history of uveitis, and the presence of corneal disease. Patients
who did not attend follow-up visits were also excluded. All patients were informed about the
treatment and the potential complications. Informed patient consents were obtained
preoperatively. The procedures of the study were approved by the institutional review board
of the hospital and adhered to the tenets of the Declaration of Helsinki. The study protocol
was approved by the local ethics committee (approval code: TUTF-BAEK 2016/213).
Before the XEN45 implantation, slit-lamp biomicroscopy and gonioscopic examination were
performed. Intraocular pressure was measured by Goldmann applanation tonometry (AT 900, Haag
Strait, Bern, Germany). A detailed fundus examination was done using a 78-dioptre
non-contact lens after pupil dilatation by 1% tropicamide gutt.
All of the surgical procedures were performed under sterile conditions by the same surgeon
(OK). Irrigation of the eyelashes, eyelids, and periorbicular tissues was performed with
antiseptic 10% povidone iodine. While using an eye speculum, 5% povidone iodine was flushed
onto the conjunctiva and fornix for two minutes; conjunctival irrigation was then completed
with saline. The surgery was performed under peribulbar anaesthesia with 5 mL prilocaine and
5 mL bupivacaine. After peribulbar anaesthesia, the superonasal quadrant of the conjunctiva
was marked by blue surgical dye 3 mm posterior to the limbus. Clear corneal incisions (main
and side-port) were created in the inferotemporal and superotemporal quadrants; a highly
cohesive viscoelastic was used to stabilise the anterior chamber during surgery. A 27-gauge
pre-loaded injector was placed into the eye through the main clear corneal incision at the
inferotemporal quadrant. The needle was directed toward the superonasal quadrant (Figure 3).
One hand was used to manipulate the injector, and the other hand was used to fix and rotate
the eye. The needle was pushed into the sclera and carried forward into the subconjunctival
space. The surgery was performed under gonioscopic control. A 6-mm-long implant was created
to be positioned 2 mm into the subconjunctival space, 3 mm into the sclera, and 1 mm into
the anterior chamber. Therefore, visualization of the tip of the needle exiting from the
sclera indicated that an optimal 3-mm intrascleral tunnel had been formed. The XEN45 implant
was deployed by rotating a dial on the inserter. Once bleb formation was seen, the needle
was withdrawn. The viscoelastic material was aspirated, and then 0.1 ml of 1% cefuroxime was
injected into the anterior chamber. Finally, the clear corneal incisions were hydrated with
a balanced salt solution. Mitomycin C was not injected into the conjunctiva at any stage of
the surgery. Topical steroid and antibiotic treatments were applied after the surgery. A
topical steroid (prednisolone acetate 1%) was applied six or more times daily to control
postoperative intraocular inflammation. The topical steroid treatment was stopped after the
first month postoperative. Ocular massage for one minute four times daily was recommended
during the postoperative period. Needling was not performed at any of the postoperative
visits. Topical antiglaucomatous medications were added as needed according to the
postoperative IOP levels. Follow-up visits were planned for 1 day, 1 and 2 weeks, and 1, 2,
3, 6, and 12 months.
Combined surgery (XEN45 + phacoemulsification + intraocular lens) was performed in the cases
that had cataracts in addition to glaucoma. In combined surgery, the XEN45 implantation was
performed after the phacoemulsification. After the intraocular lens implantation in the
capsular sac, the anterior chamber was filled with a highly cohesive viscoelastic material.
Then, the same procedures as were described previously were carried out.
All the data were compiled into a computer file for statistical analysis, and Statistical
Package for Social Sciences for Windows 17.0 was used to perform the Wilcoxon signed ranks
test. A p value less than 0.05 was considered statistically significant.
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