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EX-PRESS® Glaucoma Filtration Device Procedure

September 18, 2017 by MitosolAdmin

What is an EX-PRESS® Glaucoma Filtration Device Procedure?

The EX-PRESS® Shunt procedure implants a stainless steel device (EX-PRESS® Glaucoma Filtration Device) under a scleral flap to allow for drainage of aqueous humor in order to relieve intraocular pressure due to glaucoma.

Photo showing Ex-PRESS Shunt implantation

The EX-PRESS® procedure is very similar to a trabeculectomy, in that a fluid path is created from the anterior chamber (inside of the eye) to the outside of the eye. The perceived value in the EX-PRESS® Shunt is that it creates a uniform and consistent sized channel for aqueous outflow into the intrascleral space. Like a trabeculectomy, the surgeon creates a scleral flap, then uses a 25-gauge needle to create a tunnel into the anterior chamber. The EX-PRESS® shunt is then implanted into the opening with a footplate flush to the surface of the sclera. The flap is brought down and sutured appropriately to regulate aqueous outflow.

Similar to a trabeculectomy, the surgeon may use mitomycin-c to suppress scarring that might disrupt fluid outflow. The procedure takes approximately 45-60 minutes. After the procedure, follow-up appointments will be scheduled to ensure intraocular pressure is at the optimal level. If needed, revisions to the flap can be made at that time. The goal of the procedure is to improve the drainage of aqueous humor out of the eye, thereby reducing excessive pressure compressing the optic nerve and causing vision loss.

EX-PRESS® Shunt Surgery Recovery

Patients with EX-PRESS® Shunt implants can expect a faster recovery than those with more invasive procedures like iridectomy of sclerectomy, according to a popular study² of trabeculectomy procedures done by Maris P, et al.  Maris also found a decrease in rates of hypotony due to the promotion of controlled drainage with the EX-PRESS® shunt.  Another study¹ highlighted a significant reduction in the risk of:

  • Inflammation
  • Pigment release
  • Bleeding from the iris
  • Vitreous prolapse

All of which resulted in fewer post-surgery visits due to complications.

Benefits of EX-PRESS® Shunt Implantation

The following table is a short-term comparison between the EX-PRESS® Glaucoma Filtration Device vs a traditional trabeculectomy.

CategoryEX-PRESS® DeviceTrabeculectomy
Effective IOP lowering²✔✔
Maintained ocular pressure²✔
Minimal inflammation and scarring³✔
Less hypotony and choroidal effusion²✔
Can be combined with cataract surgery✔✔
Fewer post-op visits¹✔
Faster visual recovery¹✔
One-year success rate∗80%51%

1. Good TJ, Kahook MY. Assessment of bleb morphologic features and postoperative outcomes after EX-PRESS® drainage device implantation versus trabeculectomy. Am J Ophthalmol. 2011 Mar;151(3):507-13.e1.

2. Maris P, et al. Comparison of trabeculectomy with EX-PRESS® miniature glaucoma device implanted under the scleral flap. J Glaucoma. Jan 2007;16(1):14-19.

3. Nyska A, et al. Biocompatibility of the EX-PRESS® miniature glaucoma drainage implant. J Glaucoma. 2003;12(3):275-280.

* de Jong L, Lafuma A, Aguadé AS, Berdeaux G. Five-year extension of a clinical trial comparing the EX-PRESS® glaucoma filtration device and trabeculectomy in primary open-angle glaucoma. Clin Ophthalmol. 2011;5:527-533.

EX-PRESS® is a registered trademark of Novartis.

WMI-036 Rev 11/2019

Filed Under: Education Tagged With: Ex-PRESS, glaucoma

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INDICATION

Mitosol® (mitomycin for solution) 0.2 mg/vial Kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.

Dosage & Administration

Mitosol® is intended for topical application to the surgical site of glaucoma filtration surgery and must be reconstituted prior to application. Sponges provided within the Mitosol® kit should be fully saturated with the entire reconstituted contents in a manner prescribed in the Instructions For Use. The sponge(s) should be applied to the treatment area for two minutes. Reconstituted Mitosol® should be used within one hour of reconstitution.

US Patents #7,806,265, #8,186,511, #D685,962, #D685,963, #9,205,075, #9,539,241 and #9,649,428; other international patents issued and pending.

Product Information

Please click here for full Product Information for Mitosol®

IMPORTANT SAFETY INFORMATION
Contraindications

Mitosol® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.

Warnings & Precautions

Cell Death: Mitomycin is cytotoxic. Use of mitomycin in concentrations higher than 0.2 mg/mL or use for longer than 2 minutes may lead to unintended corneal and/or sclera damage including thinning or perforation. Direct contact with the corneal endothelium will result in cell death. Hypotony: The use of mitomycin has been associated with an increased instance of post-operative hypotony. Cataract Development: Use in phakic patients has been correlated to a higher instance of lenticular change and cataract formation. Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to use.

Adverse Events & Reactions

The most frequent adverse reactions to Mitosol® occur locally and include hypotony, hypotony maculopathy, blebitis, endophthalmitis, vascular reactions, corneal reactions, and cataract. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.

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