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Ophthalmology. 2015 Jul;122(7):1283-93. doi: 10.1016/j.ophtha.2015.03.031. Epub 2015 May 9.

A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma.

Author information

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.

PMID:
25972254
DOI:
10.1016/j.ophtha.2015.03.031
[Indexed for MEDLINE]

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