August 2011

 

GLAUCOMA

 

In Armenia, a perfect partnership


by Faith A. Hayden EyeWorld Staff Writer
 

Glaucoma editor's corner of the world

Armenia has an underserved glaucoma population. Glaukos Corp. (Laguna Hills, Calif.) has a glaucoma device that is awaiting approval from the FDA. In an impressive display of international cooperation, Glaukos is working through the Armenian Eye Care Project to bring some of the finest North American surgeons to Armenia to implant the Glaukos devices in glaucoma patients. This project helps Armenians gain access to highly sophisticated glaucoma devices and also gives American surgeons an opportunity to gain greater familiarity with the Glaukos implants before FDA approval. The Glaukos iStent is a breakthrough concept in glaucoma control because it is implanted into Schlemm's canal and reduces intraocular pressure without requiring a filtration bleb. The absence of a bleb helps avoid many of the risks of traditional glaucoma procedures such as trabeculectomy. Glaukos has completed FDA studies for the first generation device and expects approval in the near future. The company has already developed two newer generations of the iStent, and the Armenian experience will be invaluable in assessing efficacy. The list of ophthalmologists who have traveled to Armenia for this project reads like a Who's Who of North American cataract/ glaucoma surgeons.

Reay Brown, M.D., glaucoma editor

 

 

North American surgeons, Armenians hold glaucoma intervention

Dr. Ahmed performs surgery at the Republican Eye Hospital in Yerevan, Armenia

Surgeons from North America, including Dr. Ahmed (center, in green scrubs), are working with the AECP and Glaukos to improve glaucoma care in Armenia Source: Iqbal (Ike) K. Ahmed, M.D.

Sometimes all the pieces, no matter how widespread or diverse, manage to convene in the perfect collaboration. For a glaucoma intervention at the Malayan Eye Center, Yerevan, Armenia, this meant the combining of charity, industry, and research half a world apart. Since January 2011, a team of ophthalmologists from North America has partnered with the Armenian Eye Care Project (AECP) and Glaukos Corp. (Laguna Hills, Calif.) to help bolster glaucoma care in Armenia with the iStent, a glaucoma drainage device from Glaukos. Surgeons joined Lilit Voskanyan, M.D., chief of glaucoma surgery, Republican Eye Hospital, to assist her with Armenia's large glaucoma population, as well as to gain experience working with the iStent. "This initiative is a combination of a lot of different backgrounds," said Iqbal (Ike) K.Ahmed, M.D., assistant professor, University of Toronto. "It started off as an AECP program and then built into an initiative to bring top surgeons to the area to train local surgeons. A number of surgeons that went had limited experience with the iStent, so going there provided an opportunity for them to learn as well." California-based AECP is a non-profit organization founded in 1992 to provide the war-torn country with the equipment, knowledge, and medicine it needs for proper eyecare. Richard A. Hill, M.D., Emeritus associate professor of ophthalmology, University of California, Irvine., co-founded AECP and Glaukos, and is one of the inventors of the iStent. Glaukos covered the expenses of the trip and provided the doctors with many of the surgical devices and clinical support needed.

"Armenia has a very poor population and a great need for glaucoma treatments," said Kerry D. Solomon, M.D., director, Carolina Eyecare Research Institute, South Carolina. "Standard glaucoma surgery is wrought with a high failure and complication rate. Given the economic health of the country, the medication compliance rate is very poor. Medications are expensive." The iStent, though, could be a solution to many of Armenia's glaucoma problems because it's a minimally invasive, affordable procedure. Three generationsknown as G1, G2, and G3are available in the country, and the North American doctors utilized all of them. The first generation of the device is currently sitting at the FDA awaiting approval in the United States. "The post-op care is significantly less in these procedures," said Thomas W. Samuelson, M.D., director, glaucoma service, and instructor, ophthalmic pharmacology, Regions Hospital, St. Paul, Minn. "The traditional glaucoma surgeries like trabeculectomy present the patient with life-long risk. Patients are vulnerable to infection and late complications. With the Glaukos procedure, we don't subject patients to that risk. They need continued surveillance and sometimes drug therapy, but the amount of medication needed is significantly reduced."

Doctors who traveled to Armenia included Drs. Ahmed, Solomon, and Samuelson, as well as David F. Chang, M.D., clinical professor of ophthalmology, University of California, San Francisco, and Eric D. Donnenfeld, M.D., co-chairman, cornea, Nassau University Medical Center, East Meadow, N.Y. The surgeons came to the country in intervals, each performing a different number of glaucoma surgeries with the device. Drs. Solomon and Donnenfeld, for example, performed more than 100 surgeries in 2 or 3 days using all three generations of the iStent. "It gave us a chance to get access to these new technologies," said Dr. Solomon. "Eric and I both found that we learned a great deal from the local surgeons. While we were there to teach them new techniques, we learned a lot from them as well in terms of how they integrate the newer iStents into their glaucoma methodology." Dr. Samuelson found the second-generation iStent to be a "significant advance over the first generation," he said. The G1 and G2 are similar in mechanism, but the G2 allows surgeons to implant more than one iStent into the eye without exiting. With the first generation, inserting two stents required two separate maneuvers. The G3, the iStent Supra, relies on the suprachoroidal space and is "a completely different strategy," said Dr. Samuelson. In addition to gaining experience using the different iStents, surgeons were able to implant more than one in the same eye. For example, Dr. Ahmed performed about 80 surgeries, two-thirds of which utilized multiple iStents. Because the iStent is already approved in Canada, Dr. Ahmed has had ample experience working with it. "I've already done 300 or 400 [iStent] implants here in Canada," he said. "In Armenia, we did up to three implants in one eye. In Canada, I've done up to four or five. I think two seems to be a good number for most of our patients. Our center now uses one or two depending on the pressure target." Patients in Armenia continue to be followed closely by glaucoma specialists there, and Dr. Ahmed expects to obtain a substantial amount of usable data. U.S. surgeons are hoping the G1 iStent will get FDA approval sometime in the next few months. Trials are currently underway in the U.S. looking at the G2.

"I fully expect that comprehensive ophthalmologists will be utilizing these devices on a routine basis for patients with mild to moderate glaucoma and ocular hypertension," said Dr. Solomon. "In this day and age, if we have the chance to reduce someone's dependence on glaucoma medication and sustain controlled intraocular pressure in the short and long term with a device, then that's going to be the way to go. It will be accepted by patients from a compliance and expense standpoint and will be very well accepted by comprehensive ophthalmic surgeons."

Editors' note: Drs. Ahmed, Samuelson, and Solomon have financial interests with Glaukos.

Contact information

Ahmed: ike.ahmed@utoronto.ca
Samuelson: twsamuelson@mneye.com
Solomon: kerry.solomon@carolinaeyecare. com

In Armenia, a perfect partnership In Armenia, a perfect partnership
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