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Transitioning to the EX-PRESS® Glaucoma Filtration Device

If you don’t already perform EX-PRESS® Glaucoma Filtration
Device implantations, what’s holding you back?

  I don’t think there is enough data to support it.

Actually, the EX-PRESS® Glaucoma Filtration Device has been implanted more than 125,000 times, and it has been studied extensively. Data shows that EX-PRESS® Glaucoma Filtration Device patients experienced significantly lower IOP rates compared with trabeculectomy patients for up to three years and similar rates at five years.1 They also experienced a reduced need for IOP-lowering medications at all postoperative visits within a five-year study period,1 a more rapid recovery2 and less early postoperative hypotony and choroidal effusions.2

   I’m not sure about how reimbursement works.

Use of the EX-PRESS® Glaucoma Filtration Device is covered by Medicare, as well as most commercial payers.

   I have concerns over biocompatibility and scarring.
   I’m worried that the device will interfere with MRIs.

Actually, the EX-PRESS® Glaucoma Filtration Device labeling states MRI of the head is permitted, though not recommended, in the first two weeks post implantation.4

   I don’t have any experience with the procedure.

Good news! While the EX-PRESS® Glaucoma Filtration Device is revolutionizing glaucoma surgery, it doesn’t require as much of a change for surgeons who are experienced with performing the trabeculectomy as you might expect. In fact, there are a number of similarities between the two procedures.

1. 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.

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

*Not all of the studies above involved the currently marketed P50 or P200 models. However, those models have similar performance to earlier models, which were included in some of these studies. See Directions for Use.

1. 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.

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

*Not all of the studies above involved the currently marketed P50 or P200 models. However, those models have similar performance to earlier models, which were included in some of these studies. See Directions for Use.

4. EX-PRESS® Glaucoma Filtration Device Directions for Use.

*Not all of the studies above involved the currently marketed P50 or P200 models. However, those models have similar performance to earlier models, which were included in some of these studies. See Directions for Use.

A Natural Fit with Cataract Surgery

While the EX-PRESS® Glaucoma Filtration Device is changing glaucoma surgery, it doesn’t require as much of a change as you might expect for surgeons experienced with performing trabeculectomies. In fact, there are a number of similarities between the two procedures.


Surgical Pearls and Practices

Dr. Ike Ahmed* has been working with the EX-PRESS® Glaucoma Filtration Device for more than five years, and he’s happy to share his expertise.

Watch as Dr. Ike Ahmed takes you step-by-step through a live EX-PRESS® Glaucoma Filtration Device implantation, offering pearls along the way.

*Dr. Ike Ahmed is a paid consultant of Alcon Laboratories.

Dr. Ike Ahmed walks you through glaucoma filtration surgery with the EX-PRESS® Glaucoma Filtration Device.

Watch as Dr. Ike Ahmed takes you step-by-step through a live EX-PRESS® Glaucoma Filtration Device implantation, offering pearls along the way.

*Dr. Ike Ahmed is a paid consultant of Alcon Laboratories.

Flap Location and Dissection See more

  • I usually create a fornix-based conjunctival flap, but with an added modification: I leave a small stump of conjunctiva at the limbus, which is used when the conjunctiva is sutured closed at the end of the surgery to obtain a watertight closure.
  • Prior to scleral flap dissection, the device’s entry point (the scleral spur) is determined. The flap dimensions are then pre-planned around this point. As a result, when the device is inserted, we already know that the flap will adequately cover it.
  • When measuring flap dimensions, I generally leave a space of about 1 to 1.5 mm on either side of the implant, 1 mm posteriorly and 0.5 mm anteriorly, to produce a flap size of approximately 4 mm by 3 mm.
  • I intentionally leave a 0.5 mm gap between the base of the flap and the anticipated anterior aspect of the implant to help prevent compression of the implant by the flap.
  • For surgeons who are new to this procedure, using a caliper to measure the scleral flap dimensions is recommended.
  • Once all dimensions of the scleral flap are measured out, the flap is dissected. It is dissected past the scleral spur and into the blue zone of the peripheral cornea.
  • A scleral flap of sufficient size helps to provide good control of the aqueous flow and will help guard against hypotony. I generally make a half-thickness flap.

Creating the Entry Point for the Device See more

  • The entry point should be made at the scleral spur, posterior to the edge of the limbal blue zone. Entering at the scleral spur ensures that the device is placed properly in the anterior chamber, away from the cornea and iris.
  • A 25-gauge needle or MVR blade is used to create an anterior chamber entry point for the device. Inserting it parallel with the iris is crucial so that it does not point up toward the cornea or down toward the iris.

Inserting the Device See more

  • Before attempting to insert the device through this newly created opening, I position the EX-PRESS® Glaucoma Filtration Device delivery system in my hand so that my first finger is already on the injector trigger, making it easy to release the device into place once it is correctly positioned in the eye.
  • I rotate the device 90 degrees on its side, insert it into the anterior chamber opening, and once the device is fully inserted (which is indicated by a “pop” sensation), I then turn it back to its final upright position.
  • If the device is inserted correctly, its tip will be in the anterior chamber, and the end plate of the device will be flush with the scleral bed.
  • I then inject balanced salt solution through a paracentesis to check the aqueous humor flow. Sometimes, not surprisingly, some aqueous humor may flow around the device, because it has been placed through a stretched pilot hole.

Suturing See more

  • When placing sutures intraoperatively, I use slipknots so that the tension can be titrated up or down, depending on the amount of flow that occurs as balanced salt solution is injected into the side port.
  • When the scleral flap is sutured down at the end of the procedure, I typically use two or three sutures; the goal is to provide enough resistance to ensure that the aqueous flow will be able to maintain the IOP at a target level of at least the mid-teens. I expect there to be a slight trickle of aqueous around the scleral flap, indicating adequate suture tension.
  • The conjunctival flap is sutured back using 10-0 Vicryl sutures with a running horizontal mattress technique, allowing for a watertight closure.
  • Post-op, if the sutures have been placed with adequate tension, the IOP should ideally be in the mid-teens on the first day.
  • As the IOP increases over time during bleb healing, suture lysis may be performed as needed. I usually prefer to wait at least a week before lysing the sutures, allowing an enhancement of the bleb to be formed postoperatively as needed.

Enjoy the Benefits of Lumenal Control

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EX-PRESS® Glaucoma Filtration Device +

EX-PRESS® Glaucoma Filtration Device

CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

INDICATION: The EX-PRESS® Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed.

GUIDANCE REGARDING THE SELECTION OF THE APPROPRIATE VERSION: Prior clinical studies were not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor’s discretion.

CLINICAL STUDY INFORMATION: A clinical study was performed with the EX-PRESS® Glaucoma Filtration Device versions R-30 and R-50. The study was a prospective, open-label multi-center study of 113 open angle glaucoma patients with a follow-up period of one year. Results indicated an 80.4% overall success for the per-protocol cohort (R-30 and R-50, n=58) at one year, where overall success was defined as an IOP reduction greater than 20% from baseline with or without medications. Results indicated a 75.9% overall success for the per-protocol cohort (R-30 and R-50, n=58) at one year, where overall success was defined as an IOP of less than 21 mmHg with or without medications. The mean IOP reduction at one year was 33.8%. The percentage reduction from baseline was greater than 28% for the R-30 version and greater than 40% for the R-50 version.

The overall average number of glaucoma medications dropped significantly from 1.55 pre-operative to 0.52 medications at one-year postoperative.

The clinical study was not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor’s discretion. The most commonly reported adverse events included the need for further filtering surgery, device explantation, bleb revision and iris touch. Reasons for device explantation included flat anterior chamber with hypotony, device exposure from erosion, and poor efficacy. Other adverse events such as, but not limited to, corneal and retinal complications, uveitis, and significant reduction in visual acuity, may occur as well.

CONTRAINDICATIONS: The use of this device is contraindicated if one or more of the following conditions exist:

  • Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
  • Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
  • Patients diagnosed with angle closure glaucoma.

WARNINGS/PRECAUTIONS: The use of this device is contraindicated if one or more of the following conditions exist:

  • The surgeon should be familiar with the directions for use.
  • The integrity of the package should be examined prior to use and the device should not be used if the package is damaged and sterility is compromised.
  • This device is for single use only.
  • MRI of the head is permitted, however not recommended, in the first two weeks post implantation.

ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.

EX-PRESS® Glaucoma Filtration Device

CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

INDICATION: The EX-PRESS® Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed.

GUIDANCE REGARDING THE SELECTION OF THE APPROPRIATE VERSION: Prior clinical studies were not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor’s discretion.

CLINICAL STUDY INFORMATION: A clinical study was performed with the EX-PRESS® Glaucoma Filtration Device versions R-30 and R-50. The study was a prospective, open-label multi-center study of 113 open angle glaucoma patients with a follow-up period of one year. Results indicated an 80.4% overall success for the per-protocol cohort (R-30 and R-50, n=58) at one year, where overall success was defined as an IOP reduction greater than 20% from baseline with or without medications. Results indicated a 75.9% overall success for the per-protocol cohort (R-30 and R-50, n=58) at one year, where overall success was defined as an IOP of less than 21 mmHg with or without medications. The mean IOP reduction at one year was 33.8%. The percentage reduction from baseline was greater than 28% for the R-30 version and greater than 40% for the R-50 version.

The overall average number of glaucoma medications dropped significantly from 1.55 pre-operative to 0.52 medications at one-year postoperative.

The clinical study was not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor’s discretion. The most commonly reported adverse events included the need for further filtering surgery, device explantation, bleb revision and iris touch. Reasons for device explantation included flat anterior chamber with hypotony, device exposure from erosion, and poor efficacy. Other adverse events such as, but not limited to, corneal and retinal complications, uveitis, and significant reduction in visual acuity, may occur as well.

CONTRAINDICATIONS: The use of this device is contraindicated if one or more of the following conditions exist:

  • Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
  • Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
  • Patients diagnosed with angle closure glaucoma.

WARNINGS/PRECAUTIONS: The use of this device is contraindicated if one or more of the following conditions exist:

  • The surgeon should be familiar with the directions for use.
  • The integrity of the package should be examined prior to use and the device should not be used if the package is damaged and sterility is compromised.
  • This device is for single use only.
  • MRI of the head is permitted, however not recommended, in the first two weeks post implantation.

ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.