When each of us discusses treatment options with patients with primary open-angle glaucoma (POAG) in the clinic, we are focused on determining what course of action would be best for the individual in front of us, now and in the future. The data from clinical trials may or may not be part of that conversation, but they nevertheless guide the treatment options we consider. Thus, the robustness and believability of data from a clinical trial, and to what extent a study demonstrates clinically meaningful outcomes, are important for informing the individualized risk-benefit analysis we perform for each patient. What impact the treatment may have on the patient’s quality of life is also an important consideration.
As we consider the 2- and 5-year outcomes from the HORIZON trial, we can draw some conclusions as to how they impact clinical decision-making. For example, the totality of this evidence changes the definition of success with a patient. As noted in the study, Hydrus® Microstent (Alcon) + cataract surgery (CS) resulted in a greater magnitude reduction in IOP and higher success rates compared to CS alone. Of particular interest to us is that a greater percentage of patients randomized to receive the Hydrus® Microstent achieved medication-free status, and a lower percentage required secondary surgical interventions. These data points highlight that the Hydrus® Microstent has a durable and significant impact on patients’ quality of life.1
In the HORIZON study, the data show that Hydrus® + CS provided durable postoperative pressure in the mid-teens.
Fundamentally, the array of interventions that meet the definition of minimally invasive glaucoma surgery (MIGS) has altered our approach to managing POAG. Data such as those from the HORIZON trial help to confirm that it is safe and efficacious to intervene earlier in the disease course. Based on what we have learned from well-run and robust clinical trials such as HORIZON, we now know we do not have to wait and watch uncontrolled IOP, because the safety profile of MIGS, such as the Hydrus® Microstent, is favorable enough to consider surgery even with controlled IOP.
1. Ahmed IIK, De Francesco T, Rhee D, et al; HORIZON Investigators. Long-term outcomes from the HORIZON Randomized Trial for a schlemm’s canal microstent in combination cataract and glaucoma surgery. Ophthalmology. 2022;129(7):742-751.
INDICATIONS FOR USE: The Hydrus® Microstent is intended for the reduction of intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) as a standalone treatment or in conjunction with cataract surgery.
CONTRAINDICATIONS: The Hydrus® Microstent is contraindicated under the following circumstances or conditions: (1) In eyes with angle closure glaucoma; (2) In eyes with secondary glaucoma such as neovascular glaucoma or uveitic glaucoma; (3) Patients with known nickel allergy; (4) Pediatric patients less than 18 years of age.
WARNINGS: Clear media for adequate visualization is required. Conditions such as corneal haze, corneal opacity or other conditions may inhibit gonioscopic view of the intended implant location. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, peripheral anterior synechiae (PAS), angle closure, rubeosis and any other angle abnormalities that could lead to improper placement of the stent and pose a hazard.
PRECAUTIONS: The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the Hydrus® Microstent has not been established as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, eyes with significant prior trauma, eyes with abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associated with vascular disorders, eyes with uveitic glaucoma, eyes with other secondary open angle glaucoma, or eyes that have undergone argon laser trabeculoplasty (ALT). The safety and effectiveness of use of more than a single Hydrus® Microstent or with other metallic implants has not been established.
ADVERSE EVENTS: The most common intra-operative and post-operative device-related ocular adverse events reported include transient hyphema; peripheral anterior synechiae without device obstruction; partial or complete device obstruction; non-persistent anterior uveitis/iritis; subconjunctival hemorrhage; and device malposition.
MRI INFORMATION: The Hydrus® Microstent is MR-Conditional meaning that the device is safe for use in a specified MR environment under specified conditions.
Please refer to product direction for use for list of indications, contraindications and warnings.
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