Trial reportBMJ open ophthalmology2025
Effectiveness and safety of the XEN45 gel stent compared to trabeculectomy in primary open-angle glaucoma: the Gold-Standard Pathway Study.
Trial report in BMJ open ophthalmology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Referral for glaucoma surgery and types of surgery in different European regions in 2025, the EURACCUR study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026Article
- Comparative efficacy and safety of ab-interno XEN 45 gel implantation versus trabeculectomy for glaucoma: a systematic review and meta-analysis.Therapeutic advances in ophthalmologyArticle
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo compare the gel stent to trabeculectomy in the Gold-Standard Pathway Study (GPS) patients with primary open-angle glaucoma (POAG).
methodsIn the GPS, patients with elevated intraocular pressure (IOP) poorly controlled with IOP-lowering medication were randomised (2:1, gel stent:trabeculectomy). Aggregate primary endpoint: patients (%) at month 12 achieving ≥20% IOP reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers or secondary surgical intervention (SSI). Secondary endpoints included changes in mean IOP and medication count from baseline; postoperative interventions; visual recovery; postoperative complications; and the Symptom and Health Problem Checklist (SHPC-18) questionnaire.
resultsOf 130 eyes with POAG treated/analysed (gel stent, n=88; trabeculectomy, n=42); 61.4% and 69.0% met the primary endpoint, respectively (p=0.394). At month 12, the change from baseline in mean IOP was statistically greater post-trabeculectomy (by 2.8 mm Hg; p=0.028) than post-gel stent. Postoperative intervention and postoperative complication rates were 39.8% and 75.0% (gel stent) versus 76.2% and 92.9% (trabeculectomy), respectively. Hypotony (IOP ≤6 mm Hg at two consecutive visits) rates were 14.8% (gel stent) and 28.6% (trabeculectomy). Visual recovery was faster/better (per the mean and time to first return to baseline best corrected visual acuity) and SHPC-18-related improvements were greater post-gel stent than post-trabeculectomy.
conclusionSimilar proportions of eyes with POAG achieved the primary endpoint post-gel stent and post-trabeculectomy. The mean IOP reduction was statistically greater post-trabeculectomy. The gel stent resulted in fewer postoperative interventions, faster/better visual recovery, favourable patient-reported outcomes and fewer specific adverse events, although more SSIs and IOP elevations were observed.
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