Minimally invasive, novel system achieves significant pressure level reductions.
A minimally invasive glaucoma surgical device called the STREAMLINE surgical System from New World Medical, Inc successfully lowered intraocular pressure (IOP) level and demonstrated a good short-term safety profile, according to Gabriel Lazcano-Gomez, MD, who reported 3-month interim results with the device. Lazcano-Gomez is in private practice in Puebla, Mexico.
The surgical device is an FDA-cleared instrument for delivering small volumes of ophthalmic viscoelastic during ocular surgery. The single-use, disposable instrument consists of a polymer handset tipped with a surgical stainless steel cannula with a long, thin neck that accesses the trabecular meshwork through a clear corneal incision. An actuator button on the handset, when depressed, retracts a polymer outer sleeve from a stainless steel inner cutting cannula tip and delivers viscoelastic, facilitating transluminal dilation over several hours.
A prospective first-in-human interim analysis evaluated the surgical system in a study that included 52 eyes at 3 surgical sites. In this study, the device was used following phacoemulsification in patients with mild to moderate open-angle glaucoma (OAG) and postwashout IOP level of 22 to 34 mmHg. After the cataract procedure, the surgical procedure was performed in 1 eye. Using a surgical gonioscope, 5 applications of viscoelastic were injected into the Schlemm canal, Lazcano-Gomez explained.
The investigators collected data on IOP levels, medications, and surgical complications. The patients were followed postoperatively on day 1, week 1, and months 1 and 3.
Lazcano-Gomez reported that the average IOP level decreased significantly at each follow-up visit. Decrease in IOP level ranged from 5.5 to 8 mmHg. At month 3, the IOP level decreased by an average of 34.2% (P<.05) compared with baseline. The average number of glaucoma medications used also decreased significantly (P<.05), from 2.1 medications during the screening visit to 0.8 medications at month 3. A transient IOP level spike between week 1 and month 1 experienced by 1 patient resolved with topical treatment.
Lazcano-Gomez said he believes the device has a promising future. “The Streamline Surgical System successfully lowered the IOP [level] when used to perform transluminal dilation of Schlemm canal [when] combined with phacoemulsification in eyes with mild to moderate OAG,” Lazcano-Gomez explained. “The procedure was associated with decreased dependence on IOP [level]–lowering medications and had a favorable safety profile similar to other minimally invasive glaucoma surgical techniques.”