Norbert Pfeiffer1, Julian Garcia-Feijoo2, Jose M Martinez-de-la-Casa2, Jose M Larrosa3, Antonio Fea4, Hans Lemij5, Stefano Gandolfi6, Oliver Schwenn7, Katrin Lorenz8, Thomas W Samuelson9. 1. Department of Ophthalmology, Johannes Gutenberg-University, Mainz, Germany. Electronic address: norbert.pfeiffer@unimedizin-mainz.de. 2. Servicio de Oftalmología, Hospital Clinico San Carlos, Madrid, Spain. 3. Servicio de Oftalmología, University Hospital Miguel Servet, Zaragoza, Spain. 4. Dipartimento di Scienze Chirugia, Clinica Oculistica, University of Torino, Torino, Italy. 5. Glaucoma Service, Rotterdam Eye Hospital, Rotterdam, The Netherlands. 6. Unita di Oftalmologia, Universita Degli Studi die Parma, Dipartimento di Scienze Biomediche, Biotecnologiche e Traslazionali, Clinica Oculistica, University of Parma, Parma, Italy. 7. Bürgerhospital Frankfurt, am Main, Augenklinik, Germany. 8. Department of Ophthalmology, Johannes Gutenberg-University, Mainz, Germany. 9. Minnesota Eye Consultants, Minneapolis, Minnesota.
Abstract
PURPOSE: To assess the safety and effectiveness of the Hydrus Microstent (Ivantis, Inc, Irvine, CA) with concurrent cataract surgery (CS) for reducing intraocular pressure (IOP) in open-angle glaucoma (OAG). DESIGN: Prospective, multicenter, randomized, single-masked, controlled clinical trial. PARTICIPANTS: One hundred eyes from 100 patients 21 to 80 years of age with OAG and cataract with IOP of 24 mmHg or less with 4 or fewer hypotensive medications and a washed-out diurnal IOP (DIOP) of 21 to 36 mmHg. METHODS: On the day of surgery, patients were randomized 1:1 to undergo CS with the microstent or CS alone. Postoperative follow-up was at 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months. Washout of hypotensive medications was repeated at 12 and 24 months. MAIN OUTCOME MEASURES: Response to treatment was defined as a 20% or more decrease in washed out DIOP at 12 and 24 months of follow-up compared with baseline. Mean DIOP at 12 and 24 months, the proportion of subjects requiring medications at follow-up, and the mean number of medications were analyzed. Safety measures included change in visual acuity, slit-lamp observations, and adverse events. RESULTS: The proportion of patients with a 20% reduction in washed out DIOP was significantly higher in the Hydrus plus CS group at 24 months compared with the CS group (80% vs. 46%; P = 0.0008). Washed out mean DIOP in the Hydrus plus CS group was significantly lower at 24 months compared with the CS group (16.9±3.3 mmHg vs. 19.2±4.7 mmHg; P = 0.0093), and the proportion of patients using no hypotensive medications was significantly higher at 24 months in the Hydrus plus CS group (73% vs. 38%; P = 0.0008). There were no differences in follow-up visual acuity between groups. The only notable device-related adverse event was focal peripheral anterior synechiae (1-2 mm in length). Otherwise, adverse event frequency was similar in the 2 groups. CONCLUSIONS:Intraocular pressure was clinically and statistically significantly lower at 2 years in the Hydrus plus CS group compared with the CS alone group, with no differences in safety.
RCT Entities:
PURPOSE: To assess the safety and effectiveness of the Hydrus Microstent (Ivantis, Inc, Irvine, CA) with concurrent cataract surgery (CS) for reducing intraocular pressure (IOP) in open-angle glaucoma (OAG). DESIGN: Prospective, multicenter, randomized, single-masked, controlled clinical trial. PARTICIPANTS: One hundred eyes from 100 patients 21 to 80 years of age with OAG and cataract with IOP of 24 mmHg or less with 4 or fewer hypotensive medications and a washed-out diurnal IOP (DIOP) of 21 to 36 mmHg. METHODS: On the day of surgery, patients were randomized 1:1 to undergo CS with the microstent or CS alone. Postoperative follow-up was at 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months. Washout of hypotensive medications was repeated at 12 and 24 months. MAIN OUTCOME MEASURES: Response to treatment was defined as a 20% or more decrease in washed out DIOP at 12 and 24 months of follow-up compared with baseline. Mean DIOP at 12 and 24 months, the proportion of subjects requiring medications at follow-up, and the mean number of medications were analyzed. Safety measures included change in visual acuity, slit-lamp observations, and adverse events. RESULTS: The proportion of patients with a 20% reduction in washed out DIOP was significantly higher in the Hydrus plus CS group at 24 months compared with the CS group (80% vs. 46%; P = 0.0008). Washed out mean DIOP in the Hydrus plus CS group was significantly lower at 24 months compared with the CS group (16.9±3.3 mmHg vs. 19.2±4.7 mmHg; P = 0.0093), and the proportion of patients using no hypotensive medications was significantly higher at 24 months in the Hydrus plus CS group (73% vs. 38%; P = 0.0008). There were no differences in follow-up visual acuity between groups. The only notable device-related adverse event was focal peripheral anterior synechiae (1-2 mm in length). Otherwise, adverse event frequency was similar in the 2 groups. CONCLUSIONS: Intraocular pressure was clinically and statistically significantly lower at 2 years in the Hydrus plus CS group compared with the CS alone group, with no differences in safety.
Authors: Néstor Ventura-Abreu; Julián García-Feijoo; Marta Pazos; Marc Biarnés; Laura Morales-Fernández; José María Martínez-de-la-Casa Journal: Graefes Arch Clin Exp Ophthalmol Date: 2021-04-27 Impact factor: 3.117
Authors: Teresia Carreon; Elizabeth van der Merwe; Ronald L Fellman; Murray Johnstone; Sanjoy K Bhattacharya Journal: Prog Retin Eye Res Date: 2016-12-24 Impact factor: 21.198