Autores
Iqbal Ike K. Ahmed, MD¹; Ticiana De Francesco, MD¹˒²; Douglas Rhee, MD³; Cathleen McCabe, MD⁴; Brian Flowers, MD⁵; Gus Gazzard, MBBChir, MD⁶; Thomas W. Samuelson, MD⁷; Kuldev Singh, MD, MPH⁸, on behalf of the HORIZON Investigators.
Purpose
To present the 5-year results of the HORIZON trial comparing cataract surgery (CS) combined with an intracanalicular microstent with cataract surgery alone.
Design
Prospective, multicenter, controlled, randomized clinical trial.
Participants
Patients with cataract and primary open-angle glaucoma who were receiving one or more glaucoma medications, had a washed-out diurnal intraocular pressure (DIOP) between 22 and 34 mmHg, and had no history of prior incisional glaucoma surgery.
Methods
Eyes were randomized in a 2:1 ratio to receive either a Hydrus Microstent (HMS; Ivantis, Inc.) or no stent following successful cataract surgery.
Main Outcome Measures
The primary outcomes included intraocular pressure (IOP), glaucoma medication use, the need for repeat glaucoma surgery, visual acuity, visual field, procedure-related adverse events, and corneal endothelial cell counts.
Results
A total of 369 eyes were randomized to the HMS treatment group, while 187 eyes were randomized to the cataract surgery-only group. The study groups were well matched with respect to preoperative IOP, glaucoma medication use, washed-out DIOP, and glaucoma severity.
Five-year follow-up was completed in 80% of patients. At 5 years, a significantly greater proportion of eyes in the HMS group achieved an IOP of 18 mmHg or less without the use of glaucoma medications compared with the cataract surgery-only group (49.5% vs. 33.8%; P = 0.003).
Similarly, eyes treated with the HMS were more likely to achieve an IOP reduction of at least 20% without medications compared with eyes undergoing cataract surgery alone (54.2% vs. 32.8%; P < 0.001).
The mean number of glaucoma medications was 0.5 ± 0.9 in the HMS group and 0.9 ± 0.9 in the cataract surgery-only group (P < 0.001). Furthermore, 66% of eyes in the HMS group were medication-free compared with 46% in the cataract surgery-only group (P < 0.001).
The cumulative risk of requiring incisional glaucoma surgery was significantly lower in the HMS group than in the cataract surgery-only group (2.4% vs. 6.2%; P = 0.027, log-rank test).
Regarding corneal safety, no clinically or statistically significant differences were observed in the rate of endothelial cell loss between 3 and 60 months after surgery between the HMS and cataract surgery-only groups (P = 0.261).
Conclusions
The addition of a Schlemm’s canal microstent to cataract surgery was safe and resulted in lower intraocular pressure and reduced glaucoma medication use compared with cataract surgery alone after 5 years of follow-up.
The use of the Hydrus Microstent was also associated with a reduced need for subsequent incisional glaucoma filtration surgery.
Importantly, the long-term presence of the implant did not have an adverse effect on the corneal endothelium, supporting the long-term safety of the Hydrus Microstent in combination with cataract surgery.
Referência
Ophthalmology. 2022;129:742–751. © 2022 by the American Academy of Ophthalmology.