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

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.

• Authors: Norbert Pfeiffer, Julian Garcia-Feijoo, Jose M Martinez-de-la-Casa, Jose M Larrosa, Antonio Fea, Hans Lemij, Stefano Gandolfi, Oliver Schwenn, Katrin Lorenz, Thomas W Samuelson
• Journal: Ophthalmology (Ophthalmology) Vol. 122 Issue 7 Pg. 1283-93 (Jul 2015) ISSN: 1549-4713 [Electronic] United States
• PMID: 25972254 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antihypertensive Agents

Topics

• Adult
• Aged
• Aged, 80 and over
• Antihypertensive Agents (administration & dosage)
• Female
• Follow-Up Studies
• Glaucoma Drainage Implants
• Glaucoma, Open-Angle (physiopathology, surgery)
• Humans
• Intraocular Pressure (physiology)
• Lens Implantation, Intraocular
• Limbus Corneae (surgery)
• Male
• Middle Aged
• Phacoemulsification
• Prospective Studies
• Prosthesis Implantation
• Single-Blind Method
• Stents
• Tonometry, Ocular
• Visual Acuity (physiology)
• Visual Fields
• Young Adult