Ab-Externo MicroShunt vs. Trabeculectomy in Primary Open-Angle Glaucoma: 5-Year Safety Results from a Randomized, Multicenter Study.

PURPOSE

To compare the long-term safety of MicroShunt implantation with trabeculectomy in eyes with primary open-angle glaucoma.

DESIGN

A 3-year observational extension of a 2-year prospective randomized trial.

PARTICIPANTS

The extension study enrolled 279 patients (217 MicroShunt, 62 trabeculectomy), with 256 (198 and 58, respectively) completing the month 60 visit.

METHODS

This trial compared clinical outcomes of MicroShunt implantation with trabeculectomy, both augmented with mitomycin C. Adverse events (AEs), intraocular pressure (IOP), and IOP-lowering medication use were recorded 36, 48, and 60 months after initial randomization.

MAIN OUTCOME MEASURES

The primary outcome was the cumulative incidence of sight-threatening AEs. Secondary outcomes included all other AEs/complications, secondary interventions, and reductions in IOP and number of glaucoma medications.

RESULTS

Rates of sight-threatening AEs were 2% (n = 4) in the MicroShunt group and 0% in the trabeculectomy group, with 1 eye each in the MicroShunt group having central retinal artery occlusion, choroidal hemorrhage (after placement of a glaucoma drainage device), progressive endothelial cell loss, and pseudophakic bullous keratopathy. Only 2 of the 4 sight-threatening AEs in the MicroShunt group were deemed related to the study device or procedure. Four eyes in the MicroShunt group experienced device erosion through the conjunctiva. Increased IOP requiring treatment was more frequent (26% vs. 8%, P = 0.0017), whereas hypotony (3% vs. 13%, P = 0.038), epiretinal membrane formation (2% vs. 8%; P = 0.028), and blepharoptosis (4% vs. 11%, P = 0.048) were less frequent in the MicroShunt group. Four patients in the trabeculectomy group required surgical revision for hypotony. Changes in endothelial cell density were similar in the MicroShunt (-19% ± 22%) and trabeculectomy (-19% ± 22%) groups, with a mean between-group difference of 0.1% (P = 0.98). In the mean ± standard deviation, IOP was reduced from 20.8 ± 4.9 mmHg at baseline to 14.2 ± 4.1 mmHg at month 60 in MicroShunt eyes (mean reduction, 5.5 mmHg [26%]) and from 20.1 ± 3.9 mmHg to 10.4 ± 3.7 mmHg in trabeculectomy eyes (mean reduction, 9.1 mmHg [45%]), with a between-group difference of -4.6 mmHg (P < 0.0001).

CONCLUSIONS

Both filtering procedures demonstrated favorable safety profiles over 5 years. Most AEs through 5 years did neither necessitate reoperation nor result in vision-threatening complications. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.