TY - JOUR
T1 - A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma and Cataract
T2 - The HORIZON Study
AU - HORIZON Investigators
AU - Samuelson, Thomas W.
AU - Chang, David F.
AU - Marquis, Robert
AU - Flowers, Brian
AU - Lim, K. Sheng
AU - Ahmed, Iqbal Ike K.
AU - Jampel, Henry D.
AU - Aung, Tin
AU - Crandall, Alan S.
AU - Singh, Kuldev
AU - Walters, Tom
AU - Marquis, Robert
AU - Flowers, Brian
AU - Jones, Jason
AU - Vold, Steven D.
AU - Smith, Stephen E.
AU - Foster, Gary
AU - Greene, Brennan P.
AU - Tran, Dan B.
AU - Ansari, Husam
AU - Olander, Kenneth
AU - Atodaria, Neil
AU - McCabe, Cathleen
AU - Lewis, Richard
AU - Qazi, Mujtaba
AU - Nguyen, Quang
AU - Meier, Edward
AU - Godfrey, David
AU - El Mallah, Mohammed
AU - Levine, Jason
AU - Johnson, C. Stark
AU - Craven, E. Randy
AU - Hawkins, Richard D.
AU - Clifford, William
AU - Singh, Inder Paul
AU - Chu, Y. Ralph
AU - Crandall, Alan C.
AU - Rhee, Douglas
AU - Lim, K. Sheng
AU - Larrosa Poves, Jose Manuel
AU - Rekas, Marek
AU - Ang, Robert Edward T.
AU - Gagne, Sebastian
AU - Au, Leon
AU - Dorey, Michael
AU - Ramirez, Marina
AU - Gandolfi, Stefano
AU - Garcia-Feijoo, Julian
AU - Broadway, David
AU - Pfeiffer, Norbert
N1 - Funding Information:
The authors thank Yi-Jing Duh, PhD, of StatServe for providing statistical and data analysis. The authors especially acknowledge patients for participating in the study, investigating physicians and research staff, and the DSMB for its support and dedication.
Publisher Copyright:
© 2018 American Academy of Ophthalmology
PY - 2019/1
Y1 - 2019/1
N2 - Objective: To compare cataract surgery with implantation of a Schlemm canal microstent with cataract surgery alone for the reduction of intraocular pressure (IOP) and medication use after 24 months. Design: Prospective, multicenter, single-masked, randomized controlled trial. Participants: Subjects with concomitant primary open-angle glaucoma (POAG), visually significant cataract, and washed-out modified diurnal IOP (MDIOP) between 22 and 34 mmHg. Methods: Subjects were randomized 2:1 to receive a single Hydrus Microstent (Ivantis, Inc, Irvine, CA) in the Schlemm canal or no stent after uncomplicated phacoemulsification. Comprehensive eye examinations were conducted 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months postoperatively. Medication washout and MDIOP measurement were repeated at 12 and 24 months. Main Outcome Measures: The primary and secondary effectiveness end points were the proportion of subjects demonstrating a 20% or greater reduction in unmedicated MDIOP and change in mean MDIOP from baseline at 24 months, respectively. Hypotensive medication use was tracked throughout the course of follow-up. Safety measures included the frequency of surgical complications and adverse events. Results: A total of 369 eyes were randomized after phacoemulsification to Hydrus Microstent (HMS) and 187 to no microstent (NMS). At 24 months, unmedicated MDIOP was reduced by ≥20% in 77.3% of HMS group eyes and in 57.8% of NMS group eyes (difference = 19.5%, 95% confidence interval [CI] 11.2%–27.8%, P < 0.001). The mean reduction in 24-month unmedicated MDIOP was −7.6±4.1 mmHg (mean ± standard deviation) in the HMS group and −5.3±3.9 mmHg in the NMS group (difference = −2.3 mmHg; 95% CI, −3.0 to −1.6; P < 0.001). The mean number of medications was reduced from 1.7±0.9 at baseline to 0.3±0.8 at 24 months in the HMS group and from 1.7±0.9 to 0.7±0.9 in the NMS group (difference = −0.4 medications; P < 0.001). There were no serious ocular adverse events related to the microstent, and no significant differences in safety parameters between the 2 groups. Conclusions: This 24-month multicenter randomized controlled trial demonstrated superior reduction in MDIOP and medication use among subjects with mild-to-moderate POAG who received a Schlemm canal microstent combined with phacoemulsification compared with phacoemulsification alone.
AB - Objective: To compare cataract surgery with implantation of a Schlemm canal microstent with cataract surgery alone for the reduction of intraocular pressure (IOP) and medication use after 24 months. Design: Prospective, multicenter, single-masked, randomized controlled trial. Participants: Subjects with concomitant primary open-angle glaucoma (POAG), visually significant cataract, and washed-out modified diurnal IOP (MDIOP) between 22 and 34 mmHg. Methods: Subjects were randomized 2:1 to receive a single Hydrus Microstent (Ivantis, Inc, Irvine, CA) in the Schlemm canal or no stent after uncomplicated phacoemulsification. Comprehensive eye examinations were conducted 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months postoperatively. Medication washout and MDIOP measurement were repeated at 12 and 24 months. Main Outcome Measures: The primary and secondary effectiveness end points were the proportion of subjects demonstrating a 20% or greater reduction in unmedicated MDIOP and change in mean MDIOP from baseline at 24 months, respectively. Hypotensive medication use was tracked throughout the course of follow-up. Safety measures included the frequency of surgical complications and adverse events. Results: A total of 369 eyes were randomized after phacoemulsification to Hydrus Microstent (HMS) and 187 to no microstent (NMS). At 24 months, unmedicated MDIOP was reduced by ≥20% in 77.3% of HMS group eyes and in 57.8% of NMS group eyes (difference = 19.5%, 95% confidence interval [CI] 11.2%–27.8%, P < 0.001). The mean reduction in 24-month unmedicated MDIOP was −7.6±4.1 mmHg (mean ± standard deviation) in the HMS group and −5.3±3.9 mmHg in the NMS group (difference = −2.3 mmHg; 95% CI, −3.0 to −1.6; P < 0.001). The mean number of medications was reduced from 1.7±0.9 at baseline to 0.3±0.8 at 24 months in the HMS group and from 1.7±0.9 to 0.7±0.9 in the NMS group (difference = −0.4 medications; P < 0.001). There were no serious ocular adverse events related to the microstent, and no significant differences in safety parameters between the 2 groups. Conclusions: This 24-month multicenter randomized controlled trial demonstrated superior reduction in MDIOP and medication use among subjects with mild-to-moderate POAG who received a Schlemm canal microstent combined with phacoemulsification compared with phacoemulsification alone.
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U2 - 10.1016/j.ophtha.2018.05.012
DO - 10.1016/j.ophtha.2018.05.012
M3 - Article
C2 - 29945799
AN - SCOPUS:85048895507
SN - 0161-6420
VL - 126
SP - 29
EP - 37
JO - Ophthalmology
JF - Ophthalmology
IS - 1
ER -