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Long-term Outcomes from the HORIZON Randomized Trial for a Schlemm’s Canal Microstent in Combination Cataract and Glaucoma Surgery

2022; Elsevier BV; Volume: 129; Issue: 7 Linguagem: Inglês

10.1016/j.ophtha.2022.02.021

1549-4713

Iqbal Ike K. Ahmed, Ticiana De Francesco, Douglas J. Rhee, Cathleen M. McCabe, Brian Flowers, Gus Gazzard, Thomas W. Samuelson, Kuldev Singh,

Intraocular Surgery and Lenses

PurposeTo present the 5-year results of the HORIZON trial comparing cataract surgery (CS) combined with an intracanalicular microstent with CS alone.DesignProspective, multicenter, controlled randomized clinical trial.ParticipantsPatients with cataract and primary open-angle glaucoma treated with 1 or more glaucoma medications, washed-out diurnal intraocular pressure (DIOP) of 22 to 34 mmHg, and no prior incisional glaucoma surgery.MethodsEyes were randomized 2:1 to receive a Hydrus Microstent (HMS; Ivantis, Inc) or no stent after successful CS.Main Outcome MeasuresIntraocular pressure (IOP), glaucoma medication use, repeat glaucoma surgery, visual acuity, visual field, procedure-related adverse events, and corneal endothelial cell counts.ResultsThree hundred sixty-nine eyes were randomized to HMS treatment, and 187 eyes were randomized to CS only. Study groups were well matched for preoperative IOP, medication use, washed-out DIOP, and glaucoma severity. Five-year follow-up was completed in 80% of patients. At 5 years, the HMS group included a higher proportion of eyes with IOP of 18 mmHg or less without medications than the CS group (49.5% vs. 33.8%; P = 0.003), as well as a greater likelihood of IOP reduction of 20% or more without medications than the CS group (54.2% vs. 32.8%; P < 0.001). The number of glaucoma medications was 0.5 ± 0.9 in the HMS group and 0.9 ± 0.9 in the CS group (P < 0.001), and 66% of eyes in the HMS group were medication free compared with 46% in the CS group (P < 0.001). The cumulative risk of incisional glaucoma surgery was lower in the HMS group (2.4% vs. 6.2%; P = 0.027, log-rank test). No clinical or statistically significant differences were found in the rate of endothelial cell loss from 3 to 60 months between the HMS and CS alone groups (P = 0.261).ConclusionsThe addition of a Schlemm’s canal microstent in conjunction with CS was safe, resulted in lowered IOP and medication use, and reduced the need for postoperative incisional glaucoma filtration surgery compared with CS after 5 years. Long-term presence of the implant did not affect the corneal endothelium adversely. To present the 5-year results of the HORIZON trial comparing cataract surgery (CS) combined with an intracanalicular microstent with CS alone. Prospective, multicenter, controlled randomized clinical trial. Patients with cataract and primary open-angle glaucoma treated with 1 or more glaucoma medications, washed-out diurnal intraocular pressure (DIOP) of 22 to 34 mmHg, and no prior incisional glaucoma surgery. Eyes were randomized 2:1 to receive a Hydrus Microstent (HMS; Ivantis, Inc) or no stent after successful CS. Intraocular pressure (IOP), glaucoma medication use, repeat glaucoma surgery, visual acuity, visual field, procedure-related adverse events, and corneal endothelial cell counts. Three hundred sixty-nine eyes were randomized to HMS treatment, and 187 eyes were randomized to CS only. Study groups were well matched for preoperative IOP, medication use, washed-out DIOP, and glaucoma severity. Five-year follow-up was completed in 80% of patients. At 5 years, the HMS group included a higher proportion of eyes with IOP of 18 mmHg or less without medications than the CS group (49.5% vs. 33.8%; P = 0.003), as well as a greater likelihood of IOP reduction of 20% or more without medications than the CS group (54.2% vs. 32.8%; P < 0.001). The number of glaucoma medications was 0.5 ± 0.9 in the HMS group and 0.9 ± 0.9 in the CS group (P < 0.001), and 66% of eyes in the HMS group were medication free compared with 46% in the CS group (P < 0.001). The cumulative risk of incisional glaucoma surgery was lower in the HMS group (2.4% vs. 6.2%; P = 0.027, log-rank test). No clinical or statistically significant differences were found in the rate of endothelial cell loss from 3 to 60 months between the HMS and CS alone groups (P = 0.261). The addition of a Schlemm’s canal microstent in conjunction with CS was safe, resulted in lowered IOP and medication use, and reduced the need for postoperative incisional glaucoma filtration surgery compared with CS after 5 years. Long-term presence of the implant did not affect the corneal endothelium adversely.