Journal Article Ahead of print
PubMed: 41638527 DOI: 10.1016/j.ogla.2026.01.016
Outcomes of the 63-μm Gelatin Microstent versus 45-μm Gelatin Microstent: An International Multi-Center Study.
Ophthalmol Glaucoma
Authors: Mohammad Javad Ghanbarnia, Ticiana De Francesco, Ahmed Abdelaal, Markus Lenzhofer, Ingeborg Stalmans, Francesco Oddone, Antonio M Fea, Herbert Reitsamer, David B Yan, Iqbal Ike K Ahmed
Affiliations
- Prism Eye Institute, Mississauga, Canada; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.
- John A. Moran Eye Center, University of Utah, Salt Lake City, USA; University of Campinas, Campinas, Brazil; Clinica de Olhos De Francesco, Fortaleza, Brazil; Hospital de Olhos Leiria de Andrade, Fortaleza, Brazil.
- Department of Ophthalmology and Visual Sciences, Dalhousie University, Halifax, Canada.
- Department of Ophthalmology and Optometry, Paracelsus Medical University Salzburg, Salzburger Landeskliniken, Salzburg, Austria; Research Program Experimental Ophthalmology, Paracelsus Medical University Salzburg, Salzburger Landeskliniken, Salzburg, Austria.
- Department of Ophthalmology, University Hospitals UZ Leuven, Louvain, Belgium; Research Group of Ophthalmology, Department of Neurosciences, Catholic University KU Leuven, Louvain, Belgium.
- Glaucoma Unit, IRCCS Fondazione G.B. Bietti, Rome, Italy.
- Dipartimento di Scienze Chirurgiche-Universita di Torino, Torino, Italy.
- Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.
- Prism Eye Institute, Mississauga, Canada; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada; John A. Moran Eye Center, University of Utah, Salt Lake City, USA.
Abstract
PURPOSE
To compare the 12-month effectiveness and safety of 63-μm gelatin microstent (Xen63) with 45-μm gelatin microstent (Xen45) implantation.
DESIGN
Multicenter, retrospective cohort study.
SUBJECTS
Two hundred eyes of 200 patients (100 in each 63-μm and 45-μm gelatin microstent group), with or without phacoemulsification.
METHODS
Consecutive patients undergoing 63-μm microstent implantation at 6 centers across 4 countries (Canada, Italy, Austria, Belgium), were compared to matched controls who underwent 45-μm microstent implantation.
OUTCOME MEASURES
Primary outcome measure was the probability of complete surgical success at 1 year, defined as 1) no two consecutive IOP >14 mmHg or < 6 mmHg with two lines of vision loss; and (2) ≥20% reduction from decision IOP, without glaucoma medications or reoperations. Qualified success allowed glaucoma medications and laser trabeculoplasty. Secondary outcomes included surgical success with upper IOP cut-offs of 17mmHg and 21mmHg, postoperative IOP and medications course, complications, interventions and reoperations.
RESULTS
Complete success favored 63-μm microstent (56.9% vs 43.9%, P=0.017), using IOP cut-off of 14mmHg. 45-μm microstent was associated with increased hazard of surgical failure compared to 63-μm microstent (HR 1.9; 95% CI 1.2-3.0). Complete success using IOP cut-offs of 17 and 21mmHg, in the 63 vs 45-μm group was 60.1% vs 53.9% (P=0.156), and 60.1% vs 55.0% (P=0.243). Qualified success wasn't significantly different between the two groups using any IOP threshold (P>0.05). At 12 months, 63-μm group had significantly lower IOP (mean 14.6±7.6 vs 15.8±6.1 mmHg, P=0.021) and medication count (0.6±1.1 vs 1.1±1.5, P=0.024) compared to 45-μm group. Postoperative needling was performed in 16.0% and 18.0% of 63-μm and 45-μm microstent implanted eyes, respectively. Incidence of early postoperative choroidal effusion was higher in 63-μm group (25.0% vs 6.0%, P<0.001). Interventions (62.0% vs 59.0%) and reoperations (21.0% vs 15.0%) were comparable between the two groups (P>0.050).
CONCLUSIONS
The 63-μm gelatin microstent demonstrated superior IOP lowering effectiveness compared to its 45-μm variant in patients requiring more robust IOP targets. The 63-μm gelatin microstent implanted eyes required less medications to achieve their target, but experienced a higher incidence of early postoperative hypotony-related complications such as choroidal detachment, majority of which were transient.
MeSH
Eye, Multiple Chronic Conditions, Glaucoma, Gelatin