Streamline Surgical System

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 by Ahmad A. Aref, MD, MBA on February 13, 2022.


Background

The field of microinvasive glaucoma surgery (MIGS) has expanded to include a number of different procedures, techniques, and innovative tools. These procedures all have in common the goal of enhancing physiologic aqueous outflow to aid in intraocular pressure (IOP) control and to decrease risk of progressive glaucoma and associated irreversible vision loss. Some MIGS procedures involve placement of an implant while others involve modification and/or excision of tissue.

The Streamline Surgical System is a novel device intended to target the eye’s natural aqueous outflow pathways, in an implant-free fashion, to achieve IOP-lowering and decrease risk of progressive glaucomatous disease.

Device

The Streamline Surgical System (New World Medical, Inc; Rancho Cucamonga, CA, USA) is a single use device composed of a medical grade stainless steel cannula, which is housed within an outer sleeve. The outer sleeve is contained within a pump system that allows for delivery of small aliquots of viscoelastic into Schlemm’s canal. A priming port is designed for luer fitting of an external syringe and loading of the entire device with viscoelastic. An actuator button activates the pump to retract the outer sleeve (exposing the inner cannula) as well as to release viscoelastic in the into Schlemm’s canal.

Each full depression of the actuator button delivers seven microliters of viscoelastic. A maximum of eight deliveries are possible with the device.

Patient Selection

Indications

The Streamline Surgical System may be used to treat ocular hypertension and open-angle glaucomas. The procedure may be performed in standalone fashion or in combination with other ocular surgeries, including cataract surgery.

Contraindications

Contrainidications to use of the Streamline Surgical System include an inability to view the anterior chamber angle structures, patient cooperation issues, and non-consent to the procedure.

Surgical Technique

The Surgical Streamline System is first primed off of the surgical field and in sterile fashion by affixing the luer of a viscoelastic syringe to the priming port of the device. Viscoleastic is then injected into the device until emergence from the inner cannula tip is noted. Viscoleastic should be injected until air bubbles are no longer present. The procedure may be performed under topical, local, or general anesthesia.

A clear corneal incision of at least 1.8mm width should be performed in usual fashion. Surgical gonioscopy should be performed using standard techniques and an adequate and unimpeded view of the angle structures verified. The device is gripped between the thumb and middle fingers while the forefinger is rested on the actuator button. The outer sleeve is then inserted through the clear corneal incision and, under direct gonioscopic view, and into the anterior chamber. While in the anterior chamber and before intended treatment, the actuator button of the device should be pressed to release viscolastic and clear any microbubbles that may be remnant in the inner cannula. The anterior trabecular meshwork is then approached and applanated with the outer sleeve and the actuator button is firmly depressed for two seconds in order allow for protrusion of the inner cannula into Schlemm’s canal and delivery of seven microliters of viscoelastic. The actuator button should be pressed for at least two seconds to allow for complete viscoelastic delivery. Afterwards, the device is released from the trabecular meshwork and the actuator button is released to restore the inner cannula to baseline position. Multiple treatments may be administered, but the product delivers a maximum of eight boluses of viscoelastic. After completion of the desired number of treatments the device is withdrawn from the anterior chamber. Reflux bleeding may be noted from the treatment sites. Viscolastic is then cleared in usual fashion and the corneal wound is secured.

Outcomes

A prospective non-randomized, open label trial (ClinicalTrials.gov Identifier: NCT05089474) is currently underway to assess efficacy and safety outcomes with the Streamline Surgical System.

Conclusion

The Streamline Surgical System is an innovative device that is capable of performing localized goniotomies while delivering viscolastic into Schlemm’s canal. The goal of the procedure is to aid in re-establishment of physiologic aqueous outflow and to aid in IOP lowering for ocular hypertension and glaucoma.

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