6533b7cefe1ef96bd1257abc
RESEARCH PRODUCT
A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma
Norbert PfeifferJose M. LarrosaKatrin LorenzHans G LemijThomas W. SamuelsonJose M. Martinez-de-la-casaOliver SchwennStefano A. GandolfiAntonio Maria FeaJulian Garcia-feijoosubject
MaleIntraocular pressureVisual acuityMinimally invasive glaucoma surgerymedicine.medical_treatmentVisual AcuityGlaucomalaw.inventionRandomized controlled trialLens Implantation Intraocularlaw80 and overMedicineSingle-Blind MethodProspective StudiesProspective cohort studyGlaucoma Drainage ImplantsAged 80 and overIntraocularMedicine (all)Adult; Aged; Aged 80 and over; Antihypertensive Agents; Female; Follow-Up Studies; Glaucoma Open-Angle; Humans; Intraocular Pressure; Lens Implantation Intraocular; Limbus Corneae; Male; Middle Aged; Prospective Studies; Prosthesis Implantation; Single-Blind Method; Tonometry Ocular; Visual Acuity; Visual Fields; Young Adult; Glaucoma Drainage Implants; Phacoemulsification; Stents; Ophthalmology; Medicine (all)Middle AgedOpen-AngleFemaleStentsmedicine.symptomLens ImplantationGlaucoma Open-AngleAdultmedicine.medical_specialtyLimbus CorneaeTonometryProsthesis ImplantationTonometry OcularYoung AdultOphthalmologyOcularHumansAntihypertensive AgentsIntraocular PressureAgedPhacoemulsificationbusiness.industryGlaucomaPhacoemulsificationCataract surgerymedicine.diseaseOphthalmologyVisual FieldsbusinessFollow-Up Studiesdescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2014-08-20 |