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.
|Number of pages||11|
|Publication status||Published - Jul 2015|
- Aged, 80 and over
- Antihypertensive Agents/administration & dosage
- Follow-Up Studies
- Glaucoma Drainage Implants
- Glaucoma, Open-Angle/physiopathology
- Intraocular Pressure/physiology
- Lens Implantation, Intraocular
- Limbus Corneae/surgery
- Middle Aged
- Prospective Studies
- Prosthesis Implantation
- Single-Blind Method
- Tonometry, Ocular
- Visual Acuity/physiology
- Visual Fields
- Young Adult