December 2018

GLAUCOMA

Research highlight
Treating with Trabectome


by Maxine Lipner EyeWorld Senior Contributing Writer


Trabectome is an electrocautery device that ablates the trabecular meshwork and unroofs Schlemm’s canal. This allows for better drainage of the aqueous humor through the natural filtration system of the eye.
Source: Sarah Farukhi Ahmed, MD

Outcomes across the gamut

For glaucoma patients across the disease spectrum, study results indicate that with Trabectome (NeoMedix, Tustin, California) treatment, they can attain success rates of up to 93%, according to Sarah Farukhi Ahmed, MD, glaucoma fellow at University of California San Diego. Results published in Graefe’s Archive for Clinical and Experimental Ophthalmology1 are similar to those of trabeculectomy, she noted.

Initial usage

Traditionally the Trabectome as well as other types of MIGS procedures have been used for the treatment of mild glaucoma. Investigators in this study, however, wanted to see what might happen in other cases. “This study was looking at the outcomes and specifically comparing the two groups of mild and severe glaucoma and asking, ‘Can we use Trabectome in this set of patients, and what are our outcomes?’” Dr. Ahmed said.
This minimally invasive device is unique, Dr. Ahmed thinks. With this approach, the Trabectome, which has a metal tip, is inserted into trabecular meshwork where it cauterizes and unroofs Schlemm’s canal while at the same time vaporizing the trabecular meshwork. Not only does it remove the resistance that is caused by the trabecular meshwork, but it also ablates the tissue so that there is no apposition of tissue or future fibrosis so that scar formation is minimized, she said.
Unlike the more invasive trabeculectomy, which brings with it the risk of blebitis or endophthalmitis or with tubes the risk of exposure, with the Trabectome the risks are low, Dr. Ahmed stressed, adding that the procedure takes about 5 minutes. “The recovery time is almost immediate,” she said. “Patients don’t have to keep coming back for multiple visits.”
In the retrospective study, investigators had access to a multi-national database of 2,198 cases. “The unique thing about the Trabectome is that NeoMedix has a lot of data because it’s mandated that the first 20 cases that any physician does with this be reported,” Dr. Ahmed said. Investigators culled data on those patients who had at least a 1-year postoperative follow-up.

Expanding success

The success criteria in the study mirrored that of the Tube Versus Trabeculectomy study,2 Dr. Ahmed noted. Success was defined as an IOP reduction of 20% from baseline and an IOP of less than 21 mm Hg after 1 year on two consecutive visits. “Based on that criteria, we found that we had a success rate in the mild glaucoma group of 86% and in the moderate/severe group of 83%,” she said. When investigators compared these rates to those seen in the Tube Versus Trabeculectomy study, they determined that results were close. The Tube Versus Trabeculectomy study showed that the success rate with tubes was about 80% and with trabeculectomy was about 92%. When investigators further teased out those patients who had undergone cataract surgery in conjunction with Trabectome treatment, the success rate climbed to 93% in mild cases and 92% in the severe group, which was similar to trabeculectomy success rates seen in Tube Versus Trabeculectomy.
There was one small caveat. “When you looked at the number of medications that the patients were on after 1 year in the Tube Versus Trabeculectomy study, the trabeculectomy patients were on an average of one drop, but in our study, we found that the average number of medications in this post-phacoemulsification group was two,” Dr. Ahmed said. If you look at the risk/benefit overall with Trabectome including the reduction of OR time, recovery period, and number of side effects, the trade-off comes down to just one bottle of glaucoma drops, she stressed.
Dr. Ahmed was surprised by how well the severe group responded. “There’s a lot of data out there on the mild group so we were expecting that,” she said. “But the amount of IOP reduction in the severe group was something that was exciting.” She views this as opening the doorway for another means of treating severe glaucoma without having to put patients through a tough surgery like trabeculectomy or implantation of a tube shunt.
Overall, her hope is that practitioners come away from the study with a broadened sense of what the Trabectome can accomplish. “The Trabectome is a fantastic option for a microinvasive glaucoma surgery for patients anywhere along the spectrum of disease severity who require better IOP control or who want drop reduction. It is also a good option for those planning to undergo phacoemulsification and for whom you’d like a sustained IOP reduction at the same time,” Dr. Ahmed said, adding that while many think that phacoemulsification alone can lower IOP, this effect is transient.
“For patients who are anxious about going into the OR, this is a great way of making their experience there 100% worthwhile,” she said. “Maybe you can take them off a couple of drops and lower their IOP a bit as well.”

References

1. Ahmed SF, et al. Trabectome outcomes across the spectrum of glaucoma disease severity. Graefes Arch Clin Exp Ophthalmol. 2018;256:1703–1710.
2. Gedde SJ, et al. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012;153:789–803.

Editors’ note: Dr. Ahmed has no financial interests related to her comments.

Contact information

Ahmed
: sfarukhi@gmail.com

Treating with Trabectome Treating with Trabectome
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